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Trial record 28 of 315 for:    BENDAMUSTINE

Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL)

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ClinicalTrials.gov Identifier: NCT01520922
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : December 16, 2013
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia (CLL)
Leukaemia, Lymphocytic, Chronic
Interventions Biological: Ofatumumab
Drug: Bendamustine
Enrollment 99
Recruitment Details  
Pre-assignment Details Participants (par.) who met eligibility criteria at Screening were then allocated to one of the following populations: par. with previously untreated CLL or par. with relapsed CLL. A total of 99 par. were enrolled and 97 par. entered the treatment period. Study results do not include the 2 par. that were not treated in this study
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles). Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Period Title: Treatment Phase
Started 44 53
Completed 39 [1] 45 [1]
Not Completed 5 8
Reason Not Completed
Physician Decision             2             1
Progression             0             2
Adverse Event             3             5
[1]
Completed 6 Cycles of Study Treatment
Period Title: Follow up
Started 44 45
Completed 44 44
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Period Title: Survival Follow-up
Started 21 40
Completed 20 40
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2 Total
Hide Arm/Group Description Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles). Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles). Total of all reporting groups
Overall Number of Baseline Participants 44 53 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 53 participants 97 participants
63.2  (10.11) 66.5  (9.28) 65.0  (9.76)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 53 participants 97 participants
Female
15
  34.1%
17
  32.1%
32
  33.0%
Male
29
  65.9%
36
  67.9%
65
  67.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 53 participants 97 participants
White - White/Caucasian/European Heritage 42 53 95
White - Arabic/North African Heritage 1 0 1
African American/African Heritage 1 0 1
1.Primary Outcome
Title Number of Participants With Overall Response (OR), as Assessed by the Investigator
Hide Description OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.
Time Frame From the start of study treatment until 3 months after the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated subjects (ATS) Population: all participants who received at least one dose of both study drugs (ofatumumab and bendamustine). OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
CR 19 6
CRi 2 2
nPR 4 8
PR 17 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ofatumumab + Bendamustine 90 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 95
Confidence Interval (2-Sided) 95%
84.53 to 99.44
Estimation Comments The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 90 mg/m^2.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ofatumumab + Bendamustine 70 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 74
Confidence Interval (2-Sided) 95%
59.67 to 84.74
Estimation Comments The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 70 mg/m^2.
2.Secondary Outcome
Title Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator
Hide Description OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.
Time Frame From the start of study treatment until 3 months after the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
CR 12 5
CRi 1 2
nPR 2 6
PR 22 24
3.Secondary Outcome
Title Number of Participants With Complete Response (CR) With and Without a CT Scan Assessment After the Last Dose of Study Treatment, as Assessed by the Investigator
Hide Description Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500/µL, platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 g/dL, lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule.
Time Frame From the start of study treatment until 3 months after the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
CR without CT scan assessment 19 6
CR with CT scan assessment 12 5
4.Secondary Outcome
Title Investigator-assessed Kaplan-meier Estimates of Time to Response
Hide Description Time to response is defined as time from date of the first administration of study treatment to the first response (CR, CRi, nPR, or PR). Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR: all of the following criteria at least 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/ thrombocytopenia/ neutropenia unrelated to CLL but related to drug toxicity. nPR: persistent nodules BM. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11.0 g/dL or 50% improvement over BL, LC <4000/µL.
Time Frame From the start of study treatment to the first response (CR, CRi, nPR, or PR) (up to 3 Month Follow-up (F/U) visit)
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Only participants who had a response (CR, CRi, nPR, or PR) were evaluated.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 43 47
Median (95% Confidence Interval)
Unit of Measure: Months
0.95
(0.95 to 1.02)
1.08
(0.95 to 1.87)
5.Secondary Outcome
Title Investigator-assessed Kaplan-meier Estimates of Duration of Response
Hide Description The duration of response is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of disease progression (PD) or death due to any cause. PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.
Time Frame From time of initial response (CR, CRi, nPR, or PR) to disease progression or death, whichever came first (up to 3 years after the last doseof study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Only participants with an initial response (CR, CRi, nPR, or PR) with PD or death were assessed for duration of response.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 20 35
Median (95% Confidence Interval)
Unit of Measure: Months
35.15
(33.05 to 37.13)
21.75
(14.75 to 26.41)
6.Secondary Outcome
Title Investigator-assessed of Kaplan-meier Estimates of Progression-free Survival (PFS)
Hide Description PFS is defined as the interval of time between the date of the first administration of study treatment and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following:new lesion or increase by >=50% from BL in LC, Ly, size of liver and spleen, PL >= 50% decrease from BL, or to <100,000/uL secondary to CLL, Hb decrease of >2 g/dL from BL or to <10 g/dL secondary to CLL, CLL- transformation. Response was determined according to the IWCLL updated NCI-WG guidelines 2008. Participants who have neither progressed or died at the time of analysis were censored at the date of the last adequate assessment. If there was more than 1 scheduled visit missed, PFS is censored at the last adequate assessment of response. An adequate assessment is defined as an assessment where the investigator determined a response of CR, CRi, nPR, PR, or stable disease (SD).
Time Frame From the start of study treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects’ (ATS) population. N= Progression or Death
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 20 39
Median (95% Confidence Interval)
Unit of Measure: Months
36.07
(34.00 to 38.05)
22.54
(14.00 to 27.33)
7.Secondary Outcome
Title Investigator-assessed Kaplan-meier Estimates of Overall Survival
Hide Description OS is defined as the interval of time between the date of the first administration of study treatment and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.
Time Frame From the start of study treatment to the date of death due to any cause (up to 3 years after the last dose of study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects. N= Death
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 3 23
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median was not available because over 50% of the all treated subjects were alive.
8.Secondary Outcome
Title Investigator-Assessed Kaplan-Meier Estimates of Time to Progression
Hide Description Time to progression is defined as the time from the date of the first administration of study treatment to disease progression (PD). PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000 B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.
Time Frame From the start of study treatment to disease progression (up to 3 years after the last dose of study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects (ATS). This analysis includes patients who had progression.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 19 35
Median (95% Confidence Interval)
Unit of Measure: Months
36.0
(34.00 to 38.05)
22.67
(16.07 to 28.58)
9.Secondary Outcome
Title Time to Next Therapy
Hide Description Time to next therapy is defined as the time from the date of the first administration of study treatment until the start of the next anti-CLL therapy.
Time Frame From the start of study treatment until the start of the next anti-CLL therapy (up to 3 years after the last dose of study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Only participants that took anti-CLL therapy were evaluated.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 14 29
Median (95% Confidence Interval)
Unit of Measure: Months
31.18
(17.25 to 37.03)
16.82
(11.60 to 25.36)
10.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Hide Description An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Time Frame From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of any study treatment (ofatumumab or bendamustine).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
Any AE 43 50
Any SAE 20 25
11.Secondary Outcome
Title Change From Baseline in the Immunoglobulin (Ig) Antibodies to End of Study Treatment
Hide Description Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and end of study treatment (up to 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants who were available at the indicated time points were analyzed.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 38 43
Mean (Standard Deviation)
Unit of Measure: Gram per liter
IgA 0.0768  (0.91109) 0.0540  (0.23643)
IgG -0.714  (3.0614) -1.246  (5.3194)
IgM -0.0490  (0.29267) -0.0463  (0.16294)
12.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months
Hide Description CD5+ CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+ CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)
Hide Outcome Measure Data
Hide Analysis Population Description
ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Mean (Standard Deviation)
Unit of Measure: Cell per microliter
3 month F/U - Baseline (n=32, 31) -72622.5  (104175.69) -40644.2  (36183.14)
6 month F/U - Baseline (n=30,28) -61258.2  (42645.75) -45630.4  (40130.68)
9 month F/U - Baseline (n=37,23) -76688.7  (99375.55) -49527.3  (40728.82)
12 month F/U - Baseline (n=32,23) -77884.8  (106795.41) -43994.3  (39165.64)
15 month F/U - Baseline (n=29,21) -80997.6  (108950.32) -39985.6  (36456.16)
18 month F/U - Baseline (n=23,11) -85837.7  (120525.82) -31229.5  (28486.65)
21 month F/U - Baseline (n=17,8) -82180.6  (138188.36) -52665.1  (42250.59)
24 month F/U - Baseline (n=15,7) -92850.6  (144547.27) -37969.3  (26444.26)
27 month F/U - Baseline (n=19, 6) -82553.4  (129930.36) -24824.8  (23700.40)
30 month F/U - Baseline (n=15, 6) -96903.7  (142080.38) -30938.0  (28108.70)
33 month F/U - Baseline (n=10, 3) -65321.8  (40537.06) -38216.3  (24864.31)
36 month F/U - Baseline (n=8, 4) -52087.1  (35735.07) -30961.0  (25003.73)
13.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months
Hide Description CD5-CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5- CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)
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Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Mean (Standard Deviation)
Unit of Measure: Cell per microliter
3 month F/U - Baseline (n= 32, 31) -5800.8  (12693.09) -2052.4  (5243.64)
6 month F/U - Baseline (n= 30, 28) -3921.1  (6959.20) -3822.8  (8449.80)
9 month F/U - Baseline (n= 37, 23) -5969.7  (12277.21) -2288.4  (5724.47)
12 month F/U - Baseline (n= 32, 23) -6756.8  (13009.04) -4656.3  (9087.98)
15 month F/U - Baseline (n= 29, 21) -5323.6  (8727.91) -4256.2  (9145.23)
18 month F/U - Baseline (n= 23, 11) -4677.9  (7677.12) -5043.6  (10927.98)
21 month F/U - Baseline (n= 17, 8) -5224.2  (8477.84) -275.1  (449.28)
24 month F/U - Baseline (n= 15, 7) -4522.7  (7562.59) -224.0  (447.47)
27 month F/U - Baseline (n= 19, 6) -7259.0  (10162.96) -3870.5  (8960.80)
30 month F/U - Baseline (n= 15, 6) -7673.6  (10238.82) -3964.3  (8918.40)
33 month F/U - Baseline (n= 10, 3) -9511.2  (11834.25) -206.0  (215.84)
36 month F/U - Baseline (n= 8, 4) -8430.1  (13019.82) -5693.0  (10969.00)
14.Secondary Outcome
Title Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up
Hide Description MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the partcipants who were suspected of achieving a primary endpoint CR. Analysis of CD5+ CD19+ was performed on the bone marrow aspirate sample obtained no sooner than 2 months following the last dose of study treatment. MRD results were reported as negative or positive. The absence of MRD (negative MRD) is defined as less than one CLL cell per 10000 leukocytes.
Time Frame 3 month follow up to the 36 Month Follow-up (in 3 month interval)
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ATS Population. Number of subjects who had CR with bone marrow confirmation are included. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 16 4
Measure Type: Number
Unit of Measure: Participants
3 month F/U, MRD Positive (n=16 , 4) 7 4
3 month F/U, MRD Negative (n=16 , 4) 9 0
6 month F/U, MRD Positive (n=8 , 2) 1 1
6 month F/U, MRD Negative (n=8 , 2) 7 1
9 month F/U, MRD Positive (n=11 , 2) 3 1
9 month F/U, MRD Negative (n=11 , 2) 8 1
12 month F/U, MRD Positive (n=9 , 2) 1 1
12 month F/U, MRD Negative (n=9 , 2) 8 1
15 month F/U, MRD Positive (n=9 , 2) 3 1
15 month F/U, MRD Negative (n=9 , 2) 6 1
18 month F/U, MRD Positive (n=6 , 1) 1 0
18 month F/U, MRD Negative (n=6 , 1) 5 1
21 month F/U, MRD Positive (n=7, 1) 2 0
21 month F/U, MRD Negative (n=7 , 1) 5 1
24 month F/U, MRD Positive (n=6 , 1) 0 0
24 month F/U, MRD Negative (n=6 , 1) 6 1
27 month F/U, MRD Positive (n=3 , 1) 0 0
27 month F/U, MRD Negative (n=3 , 1) 3 1
30 month F/U, MRD Positive (n=4 , 1) 1 0
30 month F/U, MRD Negative (n=4 , 1) 3 1
33 month F/U, MRD Positive (n=4 , 1) 1 0
33 month F/U, MRD Negative (n=4 , 1) 3 1
36 month F/U, MRD Positive (n=2 , 1) 0 0
36 month F/U, MRD Negative (n=2 , 1) 2 1
15.Secondary Outcome
Title Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study
Hide Description Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.
Time Frame From start of treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)
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Safety Population: All subjects who receive at least one dose of study medication.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
No transfusions 38 33
At least one transfusion 6 20
16.Secondary Outcome
Title Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease
Hide Description AIHA is a disease where the body's immune system fails to recognize red blood cells as "self" and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented.
Time Frame From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE
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Hide Analysis Population Description
Safety Population All subjects who receive at least one dose of study medication.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
0 1
17.Secondary Outcome
Title Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator
Hide Description Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).
Time Frame From the first dose of study medication to 60 days after the last dose of study medication
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Safety Population
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
Neutropenia/Febrile neutropenia, Grade 3 8 27
Neutropenia/Febrile Neutropenia, Grade 4 9 16
Thrombocytopenia, Grade 3 1 2
Thrombocytopenia, Grade 4 0 2
Anemia, Grade 3 1 0
Anemia, Grade 4 0 0
18.Secondary Outcome
Title Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Event of Infection
Hide Description Participants with the indicated Grade 3 or Grade 4 adverse event of infection are presented. AEs were graded according to the NCI CTCAE grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).
Time Frame From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE
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Hide Analysis Population Description
Safety Population: All subjects who receive at least one dose of study medication.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
5 10
19.Secondary Outcome
Title Number of Participants With the Indicated Constitutional or B-symptoms
Hide Description Participants with the indicated constitutional or B-symptoms (night sweats, weight loss, fever or extreme fatigue) were presented for different time points.
Time Frame Screening (SCR), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 Month Follow-up (F/U)
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Hide Analysis Population Description
Safety Population: All subjects who receive at least one dose of study medication. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
SCR, night sweats, n =44, 52 19 22
SCR, weight loss, n=44, 52 4 5
SCR, fever, n=44, 52 1 2
SCR, extreme fatigue, n=44, 52 14 15
C3D1, night sweats, n =42, 49 5 2
C3D1, weight loss, n=42, 49 0 2
C3D1, fever, n=42, 49 0 0
C3D1, extreme fatigue, n=42, 49 2 4
C6D1, night sweats, n =39, 47 0 1
C6D1, weight loss, n =39, 47 0 0
C6D1, fever, n =39, 47 0 0
C6D1, extreme fatigue, n =39, 47 0 1
12 Month F/U, night sweats, n =39, 29 0 0
12 Month F/U, weight loss, n =39, 29 1 0
12 Month F/U, fever, n =39, 29 0 0
12 Month F/U, extreme fatigue, n =39, 29 0 0
24 Month F/U, night sweats, n =29, 17 0 0
24 Month F/U, weight loss, n=29, 17 0 0
24 Month F/U, fever, n=29, 17 0 0
24 Month F/U, extreme fatigue, n=29, 17 1 0
36 Month F/U, night sweats, n =21, 9 0 0
36 Month F/U, weight loss, n=21, 9 0 0
36 Month F/U, fever, n=21, 9 0 0
36 Month F/U, extreme fatigue, n=21, 9 0 0
20.Secondary Outcome
Title Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Hide Description The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.
Time Frame Baseline (BL), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 month follow up (F/U)
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Hide Analysis Population Description
Safety Population. All subjects who receive at least one dose of study medication.. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
BL, Score of 0, n=44, 53 16 23
BL, Score of 1, n=44, 53 28 29
BL, Score of 2, n=44, 53 0 1
BL, Score of 3, n=44, 53 0 0
BL, Score of 4-5, n=44, 53 0 0
C3D1, Score of 0, n=42, 48 17 27
C3D1, Score of 1, n=42, 48 25 21
C3D1, Score of 2, n=42, 48 0 0
C3D1, Score of 3, n=42, 48 0 0
C3D1, Score of 4-5, n=42, 48 0 0
C6D1, Score of 0, n=38, 47 19 27
C6D1, Score of 1, n=38, 47 19 19
C6D1, Score of 2, n=38, 47 0 1
C6D1, Score of 3, n=38, 47 0 0
C6D1, Score of 4-5, n=38, 47 0 0
12 Month F/U, Score of 0, n=39, 28 24 19
12 Month F/U, Score of 1, n=39, 28 14 8
12 Month F/U, Score of 2, n=39, 28 1 1
12 Month F/U, Score of 3, n=39, 28 0 0
12 Month F/U, Score of 4-5, n=39, 28 0 0
24 Month F/U, Score of 0, n=28, 16 16 13
24 Month F/U, Score of 1, n=28, 16 11 3
24 Month F/U, Score of 2, n=28, 16 1 0
24 Month F/U, Score of 3, n=28, 16 0 0
24 Month F/U, Score of 4-5, n=28, 16 0 0
36 Month F/U, Score of 0, n=21, 9 15 8
36 Month F/U, Score of 1, n=21, 9 5 1
36 Month F/U, Score of 2, n=21, 9 1 0
36 Month F/U, Score of 3, n=21, 9 0 0
36 Month F/U, Score of 4-5, n=21, 9 0 0
21.Secondary Outcome
Title Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points
Hide Description The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (C Neg) results.
Time Frame Cycle 1 Day 1 (C1D1), Cycle 6 Day 1 (C6D1), 6-Month Follow-up (F/U), and any post-dose time point
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Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
C1D1, n=41, 53 0 0
C6D1, n=34, 43 0 0
6-Month F/U, n=35, 37 0 0
Any post dose time, n=42, 47 0 0
22.Secondary Outcome
Title Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline
Hide Description Lymph nodes were evaluated by physical examination which involved recording the diameter in two planes (sum of the product of the diameter [SPD]) of the largest palpable node in each of the following sites: cervical, axillary, supraclavicular, inguinal and femoral. Lymphadenopathy is defined as lymph nodes with the largest diameter greater than 1.5 centimeters. The maximum reduction in SPD from Baseline at C2D1, C3D1, C4D1, C5D1, C6D1, 3-Month F/U, 6-Month F/U and 9-Month F/U are provided.
Time Frame Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), 3-Month Follow-Up (F/U), 6-Month F/U and 9-Month F/U
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Hide Analysis Population Description
ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Mean (Standard Deviation)
Unit of Measure: cm^2 (centimeters squared)
C2D1, n=34, 35 -83.5  (23.69) -77.3  (31.62)
C3D1, n=32, 35 -92.1  (20.17) -90.9  (17.18)
C4D1, n=32, 35 -99.1  (2.67) -94.6  (11.56)
C5D1, n=29, 35 -99.6  (1.22) -96.2  (8.95)
C6D1, n=30, 33 -99.6  (2.28) -97.0  (7.78)
3-Month F/U, n=33, 32 -99.2  (3.64) -95.9  (19.17)
6-Month F/U, n=3, 1 -100.0  (0.00) -100.0 [1]   (NA)
9-Month F/U, n=1, 0 -68.4 [1]   (NA) NA [2]   (NA)
[1]
Only one participant was analyzed in this treatment arm at this time point; therefore the standard deviation cannot be calculated.
[2]
No participants were analyzed in this treatment arm at this time point.
23.Secondary Outcome
Title Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver)
Hide Description Organomegaly is the abnormal enlargement of organs. Physical examination of the liver (L) and spleen (S) were done at Screening (SCR), C3D1, C6D1, 12-Month F/U, 24-Month F/U and 36-Month F/U. The result of the physical examination of the liver (L) and spleen (S) was presented as normal (NOR), enlarged (EL) and not assessed (NOA).
Time Frame Screening (Scr), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 -Month Follow-Up (F/U)
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Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
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Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
SCR, S, NOR, n=44, 50 23 31
SCR, S, EL, n=44, 50 21 19
SCR, S, NOA, n=44, 50 0 0
SCR, L, NOR, n=44, 51 38 41
SCR, L, EL, n=44, 51 6 9
SCR, L, NOA, n=44, 51 0 1
C3D1, S, NOR, n=42, 48 37 41
C3D1, S, EL, n=42, 48 5 6
C3D1, S, NOA, n=42, 48 0 1
C3D1, L, NOR, n=42, 48 38 42
C3D1, L, EL, n=42, 48 4 5
C3D1, L, NOA, n=42, 48 0 1
C6D1, S, NOR, n=39, 46 39 43
C6D1, S, EL, n=39, 46 0 2
C6D1, S, NOA, n=39, 46 0 1
C6D1, L, NOR, n=39, 46 37 44
C6D1, L, EL, n=39, 46 2 0
C6D1, L, NOA, n=39, 46 0 2
12 Month F/U, S, NOR, n=39, 29 39 28
12 Month F/U, S, EL, n=39, 29 0 1
12 Month F/U, S, NOA, n=39, 29 0 0
12 Month F/U, L, NOR, n=39, 29 38 28
12 Month F/U, L, EL, n=39, 29 1 1
12 Month F/U, L, NOA, n=39, 29 0 0
24 Month F/U, S, NOR, n=29, 17 29 16
24 Month F/U, S, EL, n=29, 17 0 1
24 Month F/U, S, NOA, n=29, 17 0 0
24 Month F/U, L, NOR, n=29, 17 29 16
24 Month F/U, L, EL, n=29, 17 0 1
24 Month F/U, L, NOA, n=29, 17 0 0
36 Month F/U, S, NOR, n=21, 9 21 9
36 Month F/U, S, EL, n=21, 9 0 0
36 Month F/U, S, NOA, n=21, 9 0 0
36 Month F/U, L, NOR, n=21, 9 21 9
36 Month F/U, L, EL, n=21, 9 0 0
36 Month F/U, L, NOA, n=21, 9 0 0
24.Secondary Outcome
Title Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment
Hide Description Cytogenetics refers to the study of numerical and structural chromosomal abnormalities. Cytogenetics (analyzed by fluorescent in situ hybridization [FISH]) of 17p deletion, 11q deletion, 17p or 11q deletions, 6q- or +12q or 13q- deletions, and no aberration at Baseline were summarized by clinical responses after the last dose of study treatment. Clinical responses included complete remission (CR), nodular partial remission (nPR), complete response with incomplete bone marrow Recovery (CRi), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.
Time Frame From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)
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ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
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Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
17p-, CR, n=2, 6 0 0
17p-, CRi, n=2, 6 0 0
17p-, nPR, n=2, 6 0 0
17p-, PR, n=2, 6 0 1
17p-, SD, n=2, 6 1 3
17p-, PD, n=2, 6 0 2
11q-, CR, n=8, 15 3 1
11q-, CRi, No, n=8, 15 0 0
11q-, nPR, n=8, 15 1 3
11q-, PR, n=8, 15 4 7
11q-, SD, n=8, 15 0 1
11q-, PD, n=8, 15 0 3
17p- or 11q-, CR, n=10, 20 3 1
17p- or 11q-, CRi, n=10, 20 0 0
17p- or 11q-, nPR, n=10, 20 1 3
17p- or 11q-, PR, n=10, 20 4 8
17p- or 11q-, SD, n=10, 20 1 3
17p- or 11q-, PD, n=10, 20 0 5
6q- or +12q or 13q-, CR, n=20, 24 11 3
6q- or +12q or 13q-, CRi, n=20, 24 1 2
6q- or +12q or 13q-, nPR, n=20, 24 1 4
6q- or +12q or 13q-, PR, n=20, 24 7 10
6q- or +12q or 13q-, SD, n=20, 24 0 2
6q- or +12q or 13q-, PD, n=20, 24 0 2
No aberration, CR, n= 14, 8 5 2
No aberration, CRi, n= 14, 8 2 0
No aberration, nPR, n= 14, 8 3 1
No aberration, PR, n= 14, 8 4 4
No aberration, SD, n= 14, 8 0 0
No aberration, PD, n= 14, 8 0 1
25.Secondary Outcome
Title Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment
Hide Description Participants with B2M concentration of <=4000 µg/L and >4000 µg/L at Baseline and who had clinical response after the last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow Recovery (CRi), nodular partial remission (nPR), and partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.
Time Frame From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)
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ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
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Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
<= 4000 µg/L, CR, n=23, 24 9 3
<= 4000 µg/L, CRi, n=23, 24 3 2
<= 4000 µg/L, nPR, n=23, 24 4 6
<= 4000 µg/L, PR, n=23, 24 7 9
<= 4000 µg/L, SD, n=23, 24 0 2
<= 4000 µg/L, PD, n=23, 24 0 2
> 4000 µg/L, CR, n=17, 29 9 3
> 4000 µg/L, CRi, n=17, 29 0 0
> 4000 µg/L, nPR, n=17, 29 1 2
> 4000 µg/L, PR, n=17, 29 6 14
> 4000 µg/L, SD, n=17, 29 0 3
> 4000 µg/L, PD, n=17, 29 0 6
26.Secondary Outcome
Title Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment
Hide Description Participants with IgVH mutation results as mutated and unmutated status and clinical response after last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.
Time Frame From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)
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ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
IgVH Mutated (<=98 %), CR, n=12, 13 6 4
IgVH Mutated (<=98 %), CRi, n=12, 13 2 0
IgVH Mutated (<=98 %), nPR, n=12, 13 0 4
IgVH Mutated (<=98 %), PR, n=12, 13 4 2
IgVH Mutated (<=98 %), SD, n=12, 13 0 0
IgVH Mutated (<=98 %), PD, n=12, 13 0 3
IgVH unmutated (>98%), CR, n=23, 34 11 1
IgVH unmutated (>98%), CRi, n=23, 34 1 2
IgVH unmutated (>98%), nPR, n=23, 34 5 4
IgVH unmutated (>98%), PR, n=23, 34 5 18
IgVH unmutated (>98%), SD, n=23, 34 0 5
IgVH unmutated (>98%), PD, n=23, 34 0 3
27.Secondary Outcome
Title Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment
Hide Description ZAP-70 is a protein normally expressed near the surface membrane of T cells and natural killer cells. ZAP-70 in B cells is used as a prognostic marker in identifying different forms of CLL. Participants with ZAP-70 testing results intermediate (Int), positive (Pos) and negative (Neg) at Baseline and who had a clinical response after last dose of study treatment are provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.
Time Frame From the start of study treatment until earliest date of disease progression or death (up to 3 months following last dose of study treatment)
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ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
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Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 36 44
Measure Type: Number
Unit of Measure: Participants
ZAP-70, Int, CR, n=6, 6 1 1
ZAP-70, Int, CRi, n=6, 6 0 0
ZAP-70, Int, nPR, n=6, 6 0 0
ZAP-70, Int, PR, n=6, 6 3 3
ZAP-70, Int, PD, n=6, 6 0 1
ZAP-70, Int, SD, n=6, 6 1 0
ZAP-70, Neg, CR, n=2, 2 1 0
ZAP-70, Neg, CRi, n=2, 2 0 0
ZAP-70, Neg, nPR, n=2, 2 0 0
ZAP-70, Neg, PR, n=2, 2 1 2
ZAP-70, Neg, PD, n=2, 2 0 0
ZAP-70, Neg, SD, n=2, 2 0 0
ZAP-70, Pos, CR, n=36, 44 17 5
ZAP-70, Pos, CRi, n=36, 44 3 2
ZAP-70, Pos, nPR, n=36, 44 5 8
ZAP-70, Pos, PR, n=36, 44 11 17
ZAP-70, Pos, PD, n=36, 44 0 7
ZAP-70, Pos, SD, n=36, 44 0 5
28.Secondary Outcome
Title Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR)
Hide Description An Infusion reaction is defined as events occurring after the beginning of an infusion of ofatumumab or within 24 hours following the end of an infusion of bendamustine.
Time Frame From the first dose of study medication to 60 days after the last dose of study medication (up to 24 hours after last dose of study treatment)
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Safety Population: All subjects who receive at least one dose of study medication.
Arm/Group Title Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
Hide Arm/Group Description:
Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
Overall Number of Participants Analyzed 44 53
Measure Type: Number
Unit of Measure: Participants
Any ofatumumab only IR 30 34
Any ofatumumab only SIR 3 4
Any ofatumumab plus bendamustine IR 30 35
Any ofatumumab plus bendamustine SIR 4 4
Time Frame From the first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE.
Adverse Event Reporting Description Serious adverse events (SAEs) and and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of any study drug (ofatumumab or bendamustine).
 
Arm/Group Title Ofatumumab + Bendamustine 70mg/m^2 Ofatumumab + Bendamustine 90mg/m^2
Hide Arm/Group Description Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles). Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
All-Cause Mortality
Ofatumumab + Bendamustine 70mg/m^2 Ofatumumab + Bendamustine 90mg/m^2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ofatumumab + Bendamustine 70mg/m^2 Ofatumumab + Bendamustine 90mg/m^2
Affected / at Risk (%) Affected / at Risk (%)
Total   25/53 (47.17%)   20/44 (45.45%) 
Blood and lymphatic system disorders     
Anaemia  1  1/53 (1.89%)  3/44 (6.82%) 
Febrile neutropenia  1  4/53 (7.55%)  1/44 (2.27%) 
Haemolytic anaemia  1  1/53 (1.89%)  0/44 (0.00%) 
Neutropenia  1  3/53 (5.66%)  2/44 (4.55%) 
Thrombocytopenia  1  0/53 (0.00%)  1/44 (2.27%) 
Cardiac disorders     
Acute coronary syndrome  1  2/53 (3.77%)  0/44 (0.00%) 
Cardiac arrest  1  1/53 (1.89%)  0/44 (0.00%) 
Cardio-respiratory arrest  1  2/53 (3.77%)  0/44 (0.00%) 
Sinus bradycardia  1  1/53 (1.89%)  0/44 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/53 (1.89%)  0/44 (0.00%) 
Colitis  1  1/53 (1.89%)  0/44 (0.00%) 
Inguinal hernia  1  1/53 (1.89%)  1/44 (2.27%) 
Rectal haemorrhage  1  0/53 (0.00%)  1/44 (2.27%) 
General disorders     
Chills  1  1/53 (1.89%)  0/44 (0.00%) 
General physical health deterioration  1  1/53 (1.89%)  0/44 (0.00%) 
Oedema peripheral  1  1/53 (1.89%)  0/44 (0.00%) 
Pain  1  1/53 (1.89%)  0/44 (0.00%) 
Pyrexia  1  3/53 (5.66%)  3/44 (6.82%) 
Immune system disorders     
Anaphylactic reaction  1  0/53 (0.00%)  1/44 (2.27%) 
Drug hypersensitivity  1  1/53 (1.89%)  0/44 (0.00%) 
Hypogammaglobulinaemia  1  0/53 (0.00%)  1/44 (2.27%) 
Type IV hypersensitivity reaction  1  0/53 (0.00%)  1/44 (2.27%) 
Infections and infestations     
Aspergillus infection  1  1/53 (1.89%)  0/44 (0.00%) 
Bronchitis  1  1/53 (1.89%)  0/44 (0.00%) 
Erysipelothrix infection  1  1/53 (1.89%)  0/44 (0.00%) 
Lower respiratory tract infection  1  0/53 (0.00%)  1/44 (2.27%) 
Lung infection  1  0/53 (0.00%)  1/44 (2.27%) 
Pharyngitis  1  0/53 (0.00%)  1/44 (2.27%) 
Pneumocystis jirovecii pneumonia  1  1/53 (1.89%)  0/44 (0.00%) 
Pneumonia  1  3/53 (5.66%)  0/44 (0.00%) 
Pneumonia cytomegaloviral  1  1/53 (1.89%)  0/44 (0.00%) 
Pseudomonas infection  1  1/53 (1.89%)  0/44 (0.00%) 
Pulmonary tuberculosis  1  0/53 (0.00%)  1/44 (2.27%) 
Respiratory tract infection bacterial  1  1/53 (1.89%)  0/44 (0.00%) 
Sepsis  1  1/53 (1.89%)  0/44 (0.00%) 
Septic shock  1  1/53 (1.89%)  0/44 (0.00%) 
Staphylococcal bacteraemia  1  1/53 (1.89%)  0/44 (0.00%) 
Urinary tract infection  1  1/53 (1.89%)  0/44 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture  1  0/53 (0.00%)  1/44 (2.27%) 
Infusion related reaction  1  0/53 (0.00%)  2/44 (4.55%) 
Radius fracture  1  0/53 (0.00%)  1/44 (2.27%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  0/53 (0.00%)  1/44 (2.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  0/53 (0.00%)  1/44 (2.27%) 
Basal cell carcinoma  1  0/53 (0.00%)  1/44 (2.27%) 
Bowen's disease  1  1/53 (1.89%)  0/44 (0.00%) 
Lung neoplasm malignant  1  0/53 (0.00%)  1/44 (2.27%) 
Squamous cell carcinoma  1  1/53 (1.89%)  0/44 (0.00%) 
Squamous cell carcinoma of skin  1  1/53 (1.89%)  1/44 (2.27%) 
Renal and urinary disorders     
Acute kidney injury  1  2/53 (3.77%)  1/44 (2.27%) 
Renal failure  1  0/53 (0.00%)  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/53 (1.89%)  0/44 (0.00%) 
Lung consolidation  1  1/53 (1.89%)  0/44 (0.00%) 
Pulmonary embolism  1  2/53 (3.77%)  0/44 (0.00%) 
Skin and subcutaneous tissue disorders     
Acute febrile neutrophilic dermatosis  1  1/53 (1.89%)  0/44 (0.00%) 
Rash erythematous  1  0/53 (0.00%)  1/44 (2.27%) 
Toxic skin eruption  1  1/53 (1.89%)  0/44 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ofatumumab + Bendamustine 70mg/m^2 Ofatumumab + Bendamustine 90mg/m^2
Affected / at Risk (%) Affected / at Risk (%)
Total   49/53 (92.45%)   40/44 (90.91%) 
Blood and lymphatic system disorders     
Anaemia  1  5/53 (9.43%)  5/44 (11.36%) 
Neutropenia  1  32/53 (60.38%)  20/44 (45.45%) 
Thrombocytopenia  1  12/53 (22.64%)  7/44 (15.91%) 
Gastrointestinal disorders     
Abdominal pain  1  3/53 (5.66%)  2/44 (4.55%) 
Abdominal pain upper  1  4/53 (7.55%)  5/44 (11.36%) 
Constipation  1  5/53 (9.43%)  6/44 (13.64%) 
Diarrhoea  1  7/53 (13.21%)  5/44 (11.36%) 
Nausea  1  16/53 (30.19%)  19/44 (43.18%) 
Vomiting  1  4/53 (7.55%)  5/44 (11.36%) 
General disorders     
Asthenia  1  3/53 (5.66%)  5/44 (11.36%) 
Chills  1  3/53 (5.66%)  5/44 (11.36%) 
Fatigue  1  8/53 (15.09%)  7/44 (15.91%) 
Malaise  1  4/53 (7.55%)  0/44 (0.00%) 
Oedema peripheral  1  4/53 (7.55%)  3/44 (6.82%) 
Pyrexia  1  8/53 (15.09%)  10/44 (22.73%) 
Infections and infestations     
Bronchitis  1  3/53 (5.66%)  2/44 (4.55%) 
Herpes simplex  1  3/53 (5.66%)  0/44 (0.00%) 
Nasopharyngitis  1  3/53 (5.66%)  1/44 (2.27%) 
Upper respiratory tract infection  1  5/53 (9.43%)  3/44 (6.82%) 
Urinary tract infection  1  2/53 (3.77%)  3/44 (6.82%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  8/53 (15.09%)  3/44 (6.82%) 
Investigations     
Blood creatinine increased  1  3/53 (5.66%)  3/44 (6.82%) 
Weight decreased  1  3/53 (5.66%)  2/44 (4.55%) 
Metabolism and nutrition disorders     
Decreased appetite  1  5/53 (9.43%)  6/44 (13.64%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/53 (3.77%)  4/44 (9.09%) 
Back pain  1  3/53 (5.66%)  5/44 (11.36%) 
Bone pain  1  0/53 (0.00%)  3/44 (6.82%) 
Pain in extremity  1  3/53 (5.66%)  1/44 (2.27%) 
Nervous system disorders     
Dizziness  1  3/53 (5.66%)  5/44 (11.36%) 
Headache  1  6/53 (11.32%)  6/44 (13.64%) 
Psychiatric disorders     
Insomnia  1  2/53 (3.77%)  6/44 (13.64%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/53 (7.55%)  3/44 (6.82%) 
Dyspnoea  1  3/53 (5.66%)  5/44 (11.36%) 
Oropharyngeal pain  1  3/53 (5.66%)  1/44 (2.27%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  5/53 (9.43%)  3/44 (6.82%) 
Erythema  1  2/53 (3.77%)  3/44 (6.82%) 
Pruritus  1  4/53 (7.55%)  7/44 (15.91%) 
Rash  1  7/53 (13.21%)  12/44 (27.27%) 
Urticaria  1  3/53 (5.66%)  6/44 (13.64%) 
Vascular disorders     
Flushing  1  5/53 (9.43%)  1/44 (2.27%) 
Phlebitis  1  0/53 (0.00%)  3/44 (6.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01520922     History of Changes
Other Study ID Numbers: 115991
2011-005178-43 ( EudraCT Number )
First Submitted: January 19, 2012
First Posted: January 30, 2012
Results First Submitted: October 10, 2013
Results First Posted: December 16, 2013
Last Update Posted: January 19, 2017