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A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01077622
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : January 27, 2012
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukaemia, Lymphocytic, Chronic
Intervention Drug: ofatumumab 100 mg, 1000 mg / vial
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ofatumumab
Hide Arm/Group Description Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Period Title: Overall Study
Started 10
Completed 7
Not Completed 3
Reason Not Completed
Physician Decision             2
Withdrawal by Subject             1
Arm/Group Title Ofatumumab
Hide Arm/Group Description Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
66.3  (5.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 10 participants
Asian - East Asian Heritage 1
Asian - Japanese Heritage 9
1.Primary Outcome
Title Number of Participants With a Dose-limiting Toxicity (DLT)
Hide Description A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) >=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as >= G3 until the next day); and any of following: >= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: all participants who received at least one dose of investigational drug. The first 3 participants enrolled in the study were evaluated for DLT according to study design.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator
Hide Description Par. were evaluated in accordance with the National Cancer Institute-sponsored Working Group. CR: no lymphadenopathy (Ly)/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils >=1.5*10^9/liter (L), platelets >100*10^9/L, hemoglobin >11.0 grams/deciliter, lymphocytes (LC) <4.0*10^9/L, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to chronic lymphocytic leukemia but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen, etc. nPR: nodules in BM.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of participants
SERC 70
Investigator 70
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ofatumumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 70
Confidence Interval (2-Sided) 95%
34.8 to 93.3
Estimation Comments SERC assessment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ofatumumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 70
Confidence Interval (2-Sided) 95%
34.8 to 93.3
Estimation Comments Investigator assessment
3.Secondary Outcome
Title Progression-free Survival (PFS) as Assessed by a SERC
Hide Description PFS is defined as the time from the start of treatment to the first documented sign of progressive disease (PD) or death due to any cause (whichever occurs earlier).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: only those participants who progressed or died during the study were evaluated.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 2
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(36.1 to NA)
[1]
Because the number of evaluable participants is small (2/10), it is not possible to estimate the median value and the upper limit of the 95% confidence interval of the median value for PFS.
4.Secondary Outcome
Title Duration of Response as Assessed by a SERC
Hide Description Duration of response is defined as the time from the first documented evidence of PR or better until the first documented sign of PD or death due to any reason in participants with PR or better.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 7
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
None of the seven responders progressed at the time of the analysis; thus, no data can be presented.
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from the first infusion of investigational drug to death due to any cause.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
All 10 participants were alive at the time of last follow-up.
6.Secondary Outcome
Title Time to Response as Assessed by a SERC
Hide Description Time to response is defined as the time from the first infusion of investigational drug to the first response (PR or better).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 7
Median (95% Confidence Interval)
Unit of Measure: Weeks
8.1
(8.0 to 24.1)
7.Secondary Outcome
Title Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC
Hide Description Time to next CLL therapy is defined as the time from the first infusion of investigational drug to the first administration of the next CLL treatment. CLL therapy includes anti-cancer chemotherapy, anti-cancer radiotherapy, radio-immunotherapy, and antibody therapy.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: only those participants who received CLL therapy were evaluated.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 2
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
[1]
Because the number of evaluable participants is small (2/10), it is not possible to calculate the median value for time to next CLL therapy.
8.Secondary Outcome
Title Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Hide Description Blood samples of the participants were collected for the assessment of hemoglobin.
Time Frame Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
Day 1, n=10 115.7  (15.44)
Week 1, n=10 116.0  (15.46)
Week 2, n=10 117.4  (16.37)
Week 3, n=10 117.0  (18.68)
Week 4, n=10 116.1  (18.53)
Week 5, n=10 116.4  (17.83)
Week 6, n=10 118.1  (16.25)
Week 7, n=10 118.4  (20.06)
Week 8, n=10 119.8  (20.35)
Week 12, n=10 122.6  (20.55)
Week 16, n=10 125.6  (21.08)
Week 20, n=10 127.8  (21.81)
Week 24, n=10 127.8  (22.31)
Week 28, n=9 126.2  (21.49)
Week 36, n=9 128.1  (20.91)
Week 48, n=7 137.1  (11.01)
9.Secondary Outcome
Title Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Hide Description Blood samples of the participants were collected for the assessment of lymphocytes.
Time Frame Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Giga (10^9) per liter (GI/L)
Day 1, n=10 42.6038  (41.66244)
Week 1, n=10 29.6861  (33.19072)
Week 2, n=10 8.2290  (6.76264)
Week 3, n=10 6.9065  (6.81649)
Week 4, n=10 4.0446  (2.70652)
Week 5, n=10 2.9535  (1.47227)
Week 6, n=10 2.8063  (1.43681)
Week 7, n=10 2.4792  (1.20853)
Week 8, n=10 2.1515  (0.94237)
Week 12, n=10 1.8058  (0.95653)
Week 16, n=10 1.9575  (1.09880)
Week 20, n=10 1.8388  (1.22494)
Week 24, n=10 1.8500  (1.33979)
Week 28, n=9 1.6405  (1.05653)
Week 36, n=9 3.5754  (5.38456)
Week 48, n=7 1.5099  (0.72285)
10.Secondary Outcome
Title Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator
Hide Description Bone marrow (BM) aspiration was performed, and the bone marrow smears were prepared for the assessment of lymphocytes in the BM.
Time Frame Weeks 8, 16, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Percentage of lymphocytes in the BM
Week 8, n=8 57.90  (23.492)
Week 16, n=5 38.04  (14.647)
Week 24, n=7 36.96  (14.961)
Week 36, n=6 30.00  (17.030)
Week 48, n=5 23.26  (9.651)
11.Secondary Outcome
Title Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Hide Description Blood samples of the participants were collected for the assessment of total neutrophils.
Time Frame Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: GI/L
Day 1, n=10 4.3103  (1.91880)
Week 1, n=10 3.9316  (2.37732)
Week 2, n=10 3.2158  (1.62185)
Week 3, n=10 2.7873  (1.16531)
Week 4, n=10 2.4570  (1.22611)
Week 5, n=10 2.3908  (0.99250)
Week 6, n=10 2.1747  (1.00743)
Week 7, n=10 2.1612  (1.22393)
Week 8, n=10 2.2136  (1.22993)
Week 12, n=10 1.9814  (0.90783)
Week 16, n=10 1.9915  (1.00746)
Week 20, n=10 2.2165  (1.29881)
Week 24, n=10 2.3093  (1.18840)
Week 28, n=9 2.2069  (1.57995)
Week 36, n=9 2.3482  (1.04228)
Week 48, n=7 3.0431  (1.67580)
12.Secondary Outcome
Title Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Hide Description Blood samples of the participants were collected for the assessment of platelets.
Time Frame Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: GI/L
Day 1, n=10 106.5  (31.69)
Week 1, n=10 104.0  (45.45)
Week 2, n=10 100.1  (37.21)
Week 3, n=10 118.3  (40.90)
Week 4, n=10 114.9  (46.26)
Week 5, n=10 111.5  (47.11)
Week 6, n=10 115.7  (49.86)
Week 7, n=10 121.4  (54.65)
Week 8, n=10 127.7  (64.44)
Week 12, n=10 120.1  (46.29)
Week 16, n=10 124.3  (46.00)
Week 20, n=10 134.0  (41.66)
Week 24, n=10 136.6  (44.14)
Week 28, n=9 128.9  (41.64)
Week 36, n=9 143.0  (43.19)
Week 48, n=7 130.7  (53.70)
13.Secondary Outcome
Title Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC
Hide Description SERC assessed bone marrow infiltration with the bone marrow smears of participants provided by trial sites.
Time Frame Weeks 8, 16, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Percentage of bone marrow infiltration
Week 8, n=8 57.90  (23.492)
Week 16, n=5 38.04  (14.647)
Week 24, n=7 36.96  (14.961)
Week 36, n=6 29.13  (17.379)
Week 48, n=5 23.26  (9.651)
14.Secondary Outcome
Title Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC
Hide Description SERC assessed lymphocytes based on the data provided by trial sites.
Time Frame Weeks 8, 16, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: GI/L
Week 8, n=8 2.0120  (1.03095)
Week 16, n=6 1.7975  (1.05163)
Week 24, n=7 1.8784  (1.56286)
Week 36, n=6 2.1213  (2.65560)
Week 48, n=5 1.6284  (0.70741)
15.Secondary Outcome
Title Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC
Hide Description SERC assessed lymphocytes in the bone marrow (BM) based on the data with BM smears provided by trial sites.
Time Frame Weeks 8, 16, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage of lymphocytes in BM
Week 8, n=8 57.90  (23.492)
Week 16, n=5 38.04  (14.647)
Week 24, n=7 36.96  (14.961)
Week 36, n=6 29.13  (17.379)
Week 48, n=5 23.26  (9.651)
16.Secondary Outcome
Title Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC
Hide Description SERC assessed total neutrophils based on the data provided by trial sites.
Time Frame Weeks 8, 16, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: GI/L
Week 8, n=8 2.3159  (1.35507)
Week 16, n=6 2.5803  (1.04075)
Week 24, n=7 2.8706  (1.39803)
Week 36, n=6 2.1957  (0.89898)
Week 48, n=5 2.6242  (1.05912)
17.Secondary Outcome
Title Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Hide Description CD19+ CD20+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Time Frame Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: GI/L
Day 1, n=10 33.1140  (39.40966)
Week 1, n=9 19.6438  (35.81756)
Week 2, n=10 0.0060  (0.01151)
Week 4, n=10 0.0565  (0.16699)
Week 6, n=10 0.0022  (0.00258)
Week 8, n=9 0.0006  (0.00136)
Week 12, n=10 0.0006  (0.00116)
Week 16, n=10 0.0003  (0.00058)
Week 20, n=10 0.0005  (0.00087)
Week 24, n=10 0.0002  (0.00037)
Week 28, n=9 0.0003  (0.00093)
Week 36, n=8 0.2525  (0.71266)
Week 48, n=7 0.0914  (0.10259)
18.Secondary Outcome
Title Number of Peripheral Blood CD20+ CD23+ Cells
Hide Description CD20+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Time Frame Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: GI/L
Day 1, n=10 19.9791  (27.06441)
Week 1, n=9 8.9466  (21.59662)
Week 2, n=10 0.0319  (0.04010)
Week 4, n=10 0.0685  (0.14483)
Week 6, n=10 0.0099  (0.01869)
Week 8, n=9 0.0047  (0.01131)
Week 12, n=10 0.0080  (0.02270)
Week 16, n=10 0.0111  (0.03162)
Week 20, n=10 0.0048  (0.01277)
Week 24, n=10 0.0057  (0.01553)
Week 28, n=9 0.0002  (0.00040)
Week 36, n=8 0.2147  (0.60466)
Week 48, n=7 0.0773  (0.09355)
19.Secondary Outcome
Title Number of Peripheral Blood CD19+ CD23+ Cells
Hide Description CD19+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Time Frame Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: GI/L
Day 1, n=10 23.8046  (28.66936)
Week 1, n=9 17.4769  (22.30923)
Week 2, n=10 4.6972  (6.14672)
Week 4, n=10 1.8230  (2.49206)
Week 6, n=10 0.4858  (0.55687)
Week 8, n=9 0.2252  (0.25765)
Week 12, n=10 0.2122  (0.26787)
Week 16, n=10 0.1961  (0.34108)
Week 20, n=10 0.1464  (0.33132)
Week 24, n=10 0.1330  (0.23961)
Week 28, n=9 0.1123  (0.26130)
Week 36, n=8 0.2687  (0.71524)
Week 48, n=7 0.0886  (0.11398)
20.Secondary Outcome
Title Number of Peripheral Blood CD19+ CD5+ Cells
Hide Description CD19+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Time Frame Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: GI/L
Day 1, n=10 36.0022  (36.64910)
Week 1, n=9 27.9129  (32.61649)
Week 2, n=10 5.4212  (6.55286)
Week 4, n=10 2.2158  (2.62609)
Week 6, n=10 0.5799  (0.63484)
Week 8, n=9 0.2338  (0.27058)
Week 12, n=10 0.2420  (0.32493)
Week 16, n=10 0.2425  (0.38048)
Week 20, n=10 0.1943  (0.38386)
Week 24, n=10 0.1719  (0.29401)
Week 28, n=9 0.1449  (0.25617)
Week 36, n=8 0.2858  (0.73543)
Week 48, n=7 0.1200  (0.14511)
21.Secondary Outcome
Title Number of Peripheral Blood CD20+ CD5+ Cells
Hide Description CD20+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Time Frame Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: GI/L
Day 1, n=10 32.9606  (39.50102)
Week 1, n=9 19.3999  (35.56146)
Week 2, n=10 0.0134  (0.01696)
Week 4, n=10 0.0493  (0.13576)
Week 6, n=10 0.0024  (0.00185)
Week 8, n=9 0.0029  (0.00136)
Week 12, n=10 0.0020  (0.00160)
Week 16, n=10 0.0062  (0.00907)
Week 20, n=10 0.0026  (0.00147)
Week 24, n=10 0.0036  (0.00258)
Week 28, n=9 0.0022  (0.00214)
Week 36, n=8 0.2597  (0.72781)
Week 48, n=7 0.0968  (0.11682)
22.Secondary Outcome
Title Number of Peripheral Blood CD23+ CD5+ Cells
Hide Description CD23+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Time Frame Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: GI/L
Day 1, n=10 22.7190  (25.17338)
Week 1, n=9 17.2018  (21.23454)
Week 2, n=10 4.5264  (6.03353)
Week 4, n=10 1.8255  (2.49671)
Week 6, n=10 0.4714  (0.50306)
Week 8, n=9 0.2095  (0.23907)
Week 12, n=10 0.2114  (0.27306)
Week 16, n=10 0.1866  (0.34514)
Week 20, n=10 0.1478  (0.32088)
Week 24, n=10 0.1327  (0.23698)
Week 28, n=9 0.1035  (0.23789)
Week 36, n=8 0.2570  (0.68983)
Week 48, n=7 0.1062  (0.13388)
23.Secondary Outcome
Title Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Hide Description Peripheral blood Ig kappa and Ig lambda were measured using flow cytometry. Abnormality of a ratio of Ig kappa and Ig lambda indicates clonality of lymphocytes. A normal range of this parameter is between 1.0 and 3.2.
Time Frame Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Ratio of Ig kappa/Ig lambda
Day 1, n=10 34.710  (38.2375)
Week 1, n=9 36.604  (36.9383)
Week 2, n=10 15.928  (26.5203)
Week 4, n=10 9.451  (25.1555)
Week 6, n=10 7.263  (20.3014)
Week 8, n=9 6.427  (16.7389)
Week 12, n=10 3.799  (8.8774)
Week 16, n=10 2.150  (3.8972)
Week 20, n=10 2.017  (3.8733)
Week 24, n=10 1.608  (2.6223)
Week 28, n=9 1.647  (2.3965)
Week 36, n=8 1.693  (1.8636)
Week 48, n=7 3.368  (5.2575)
24.Secondary Outcome
Title Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
Hide Description Night sweats are one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had night sweats at BL, and still had night sweats at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had night sweats at BL, but did not have night sweats at Week 1 are represented in the BL, yes; Week 1, no category.
Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
BL, yes; Week 1, yes; n=10 1
BL, yes; Week 1, no; n=10 0
BL, no; Week 1, yes; n=10 0
BL, no; Week 1, no; n=10 9
BL, yes; Week 2, yes; n=10 1
BL, yes; Week 2, no; n=10 0
BL, no; Week 2, yes; n=10 0
BL, no; Week 2, no; n=10 9
BL, yes; Week 3, yes; n=10 1
BL, yes; Week 3, no; n=10 0
BL, no; Week 3, yes; n=10 0
BL, no; Week 3, no; n=10 9
BL, yes; Week 4, yes; n=10 1
BL, yes; Week 4, no; n=10 0
BL, no; Week 4, yes; n=10 0
BL, no; Week 4, no; n=10 9
BL, yes; Week 5, yes; n=10 0
BL, yes; Week 5, no; n=10 0
BL, no; Week 5, yes; n=10 1
BL, no; Week 5, no; n=10 9
BL, yes; Week 6, yes; n=10 0
BL, yes; Week 6, no; n=10 0
BL, no; Week 6, yes; n=10 1
BL, no; Week 6, no; n=10 9
BL, yes; Week 7, yes; n=10 0
BL, yes; Week 7, no; n=10 0
BL, no; Week 7, yes; n=10 1
BL, no; Week 7, no; n=10 9
BL, yes; Week 8, yes; n=10 0
BL, yes; Week 8, no; n=10 0
BL, no; Week 8, yes; n=10 1
BL, no; Week 8, no; n=10 9
BL, yes; Week 12, yes; n=10 0
BL, yes; Week 12, no; n=10 0
BL, no; Week 12, yes; n=10 1
BL, no; Week 12, no; n=10 9
BL, yes; Week 16, yes; n=10 0
BL, yes; Week 16, no; n=10 0
BL, no; Week 16, yes; n=10 1
BL, no; Week 16, no; n=10 9
BL, yes; Week 20, yes; n=10 0
BL, yes; Week 20, no; n=10 0
BL, no; Week 20, yes; n=10 1
BL, no; Week 20, no; n=10 9
BL, yes; Week 24, yes; n=10 0
BL, yes; Week 24, no; n=10 0
BL, no; Week 24, yes; n=10 1
BL, no; Week 24, no; n=10 9
BL, yes; Week 28, yes; n=9 0
BL, yes; Week 28, no; n=9 0
BL, no; Week 28, yes; n=9 1
BL, no; Week 28, no; n=9 8
BL, yes; Week 36, yes; n=9 0
BL, yes; Week 36, no; n=9 0
BL, no; Week 36, yes; n=9 1
BL, no; Week 36, no; n=9 8
BL, yes; Week 48, yes; n=7 0
BL, yes; Week 48, no; n=7 0
BL, no; Week 48, yes; n=7 0
BL, no; Week 48, no; n=7 7
25.Secondary Outcome
Title Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
Hide Description Weight loss is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had weight loss at BL, and still had weight loss at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had weight loss at BL, but did not have weight loss at Week 1 are represented in the BL, yes; Week 1, no category.
Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
BL, yes; Week 1, yes; n=10 0
BL, yes; Week 1, no; n=10 0
BL, no; Week 1, yes; n=10 0
BL, no; Week 1, no; n=10 10
BL, yes; Week 2, yes; n=10 0
BL, yes; Week 2, no; n=10 0
BL, no; Week 2, yes; n=10 0
BL, no; Week 2, no; n=10 10
BL, yes; Week 3, yes; n=10 0
BL, yes; Week 3, no; n=10 0
BL, no; Week 3, yes; n=10 0
BL, no; Week 3, no; n=10 10
BL, yes; Week 4, yes; n=10 0
BL, yes; Week 4, no; n=10 0
BL, no; Week 4, yes; n=10 0
BL, no; Week 4, no; n=10 10
BL, yes; Week 5, yes; n=10 0
BL, yes; Week 5, no; n=10 0
BL, no; Week 5, yes; n=10 0
BL, no; Week 5, no; n=10 10
BL, yes; Week 6, yes; n=10 0
BL, yes; Week 6, no; n=10 0
BL, no; Week 6, yes; n=10 0
BL, no; Week 6, no; n=10 10
BL, yes; Week 7, yes; n=10 0
BL, yes; Week 7, no; n=10 0
BL, no; Week 7, yes; n=10 0
BL, no; Week 7, no; n=10 10
BL, yes; Week 8, yes; n=10 0
BL, yes; Week 8, no; n=10 0
BL, no; Week 8, yes; n=10 0
BL, no; Week 8, no; n=10 10
BL, yes; Week 12, yes; n=10 0
BL, yes; Week 12, no; n=10 0
BL, no; Week 12, yes; n=10 0
BL, no; Week 12, no; n=10 10
BL, yes; Week 16, yes; n=10 0
BL, yes; Week 16, no; n=10 0
BL, no; Week 16, yes; n=10 0
BL, no; Week 16, no; n=10 10
BL, yes; Week 20, yes; n=10 0
BL, yes; Week 20, no; n=10 0
BL, no; Week 20, yes; n=10 0
BL, no; Week 20, no; n=10 10
BL, yes; Week 24, yes; n=10 0
BL, yes; Week 24, no; n=10 0
BL, no; Week 24, yes; n=10 0
BL, no; Week 24, no; n=10 10
BL, yes; Week 28, yes; n=9 0
BL, yes; Week 28, no; n=9 0
BL, no; Week 28, yes; n=9 0
BL, no; Week 28, no; n=9 9
BL, yes; Week 36, yes; n=9 0
BL, yes; Week 36, no; n=9 0
BL, no; Week 36, yes; n=9 0
BL, no; Week 36, no; n=9 9
BL, yes; Week 48, yes; n=7 0
BL, yes; Week 48, no; n=7 0
BL, no; Week 48, yes; n=7 0
BL, no; Week 48, no; n=7 7
26.Secondary Outcome
Title Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
Hide Description Fever is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had fever at BL, and still had fever at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had fever at BL, but did not have fever at Week 1 are represented in the BL, yes; Week 1, no category.
Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
BL, yes; Week 1, yes; n=10 0
BL, yes; Week 1, no; n=10 0
BL, no; Week 1, yes; n=10 0
BL, no; Week 1, no; n=10 10
BL, yes; Week 2, yes; n=10 0
BL, yes; Week 2, no; n=10 0
BL, no; Week 2, yes; n=10 0
BL, no; Week 2, no; n=10 10
BL, yes; Week 3, yes; n=10 0
BL, yes; Week 3, no; n=10 0
BL, no; Week 3, yes; n=10 0
BL, no; Week 3, no; n=10 10
BL, yes; Week 4, yes; n=10 0
BL, yes; Week 4, no; n=10 0
BL, no; Week 4, yes; n=10 0
BL, no; Week 4, no; n=10 10
BL, yes; Week 5, yes; n=10 0
BL, yes; Week 5, no; n=10 0
BL, no; Week 5, yes; n=10 0
BL, no; Week 5, no; n=10 10
BL, yes; Week 6, yes; n=10 0
BL, yes; Week 6, no; n=10 0
BL, no; Week 6, yes; n=10 0
BL, no; Week 6, no; n=10 10
BL, yes; Week 7, yes; n=10 0
BL, yes; Week 7, no; n=10 0
BL, no; Week 7, yes; n=10 0
BL, no; Week 7, no; n=10 10
BL, yes; Week 8, yes; n=10 0
BL, yes; Week 8, no; n=10 0
BL, no; Week 8, yes; n=10 0
BL, no; Week 8, no; n=10 10
BL, yes; Week 12, yes; n=10 0
BL, yes; Week 12, no; n=10 0
BL, no; Week 12, yes; n=10 0
BL, no; Week 12, no; n=10 10
BL, yes; Week 16, yes; n=10 0
BL, yes; Week 16, no; n=10 0
BL, no; Week 16, yes; n=10 0
BL, no; Week 16, no; n=10 10
BL, yes; Week 20, yes; n=10 0
BL, yes; Week 20, no; n=10 0
BL, no; Week 20, yes; n=10 0
BL, no; Week 20, no; n=10 10
BL, yes; Week 24, yes; n=10 0
BL, yes; Week 24, no; n=10 0
BL, no; Week 24, yes; n=10 0
BL, no; Week 24, no; n=10 10
BL, yes; Week 28, yes; n=9 0
BL, yes; Week 28, no; n=9 0
BL, no; Week 28, yes; n=9 0
BL, no; Week 28, no; n=9 9
BL, yes; Week 36, yes; n=9 0
BL, yes; Week 36, no; n=9 0
BL, no; Week 36, yes; n=9 0
BL, no; Week 36, no; n=9 9
BL, yes; Week 48, yes; n=7 0
BL, yes; Week 48, no; n=7 0
BL, no; Week 48, yes; n=7 0
BL, no; Week 48, no; n=7 7
27.Secondary Outcome
Title Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
Hide Description Extreme fatigue is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had extreme fatigue at BL, and still had extreme fatigue at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had extreme fatigue at BL, but did not have extreme fatigue at Week 1 are represented in the BL, yes; Week 1, no category.
Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
BL, yes; Week 1, yes; n=10 0
BL, yes; Week 1, no; n=10 0
BL, no; Week 1, yes; n=10 0
BL, no; Week 1, no; n=10 10
BL, yes; Week 2, yes; n=10 0
BL, yes; Week 2, no; n=10 0
BL, no; Week 2, yes; n=10 0
BL, no; Week 2, no; n=10 10
BL, yes; Week 3, yes; n=10 0
BL, yes; Week 3, no; n=10 0
BL, no; Week 3, yes; n=10 0
BL, no; Week 3, no; n=10 10
BL, yes; Week 4, yes; n=10 0
BL, yes; Week 4, no; n=10 0
BL, no; Week 4, yes; n=10 0
BL, no; Week 4, no; n=10 10
BL, yes; Week 5, yes; n=10 0
BL, yes; Week 5, no; n=10 0
BL, no; Week 5, yes; n=10 0
BL, no; Week 5, no; n=10 10
BL, yes; Week 6, yes; n=10 0
BL, yes; Week 6, no; n=10 0
BL, no; Week 6, yes; n=10 0
BL, no; Week 6, no; n=10 10
BL, yes; Week 7, yes; n=10 0
BL, yes; Week 7, no; n=10 0
BL, no; Week 7, yes; n=10 0
BL, no; Week 7, no; n=10 10
BL, yes; Week 8, yes; n=10 0
BL, yes; Week 8, no; n=10 0
BL, no; Week 8, yes; n=10 0
BL, no; Week 8, no; n=10 10
BL, yes; Week 12, yes; n=10 0
BL, yes; Week 12, no; n=10 0
BL, no; Week 12, yes; n=10 0
BL, no; Week 12, no; n=10 10
BL, yes; Week 16, yes; n=10 0
BL, yes; Week 16, no; n=10 0
BL, no; Week 16, yes; n=10 0
BL, no; Week 16, no; n=10 10
BL, yes; Week 20, yes; n=10 0
BL, yes; Week 20, no; n=10 0
BL, no; Week 20, yes; n=10 0
BL, no; Week 20, no; n=10 10
BL, yes; Week 24, yes; n=10 0
BL, yes; Week 24, no; n=10 0
BL, no; Week 24, yes; n=10 0
BL, no; Week 24, no; n=10 10
BL, yes; Week 28, yes; n=9 0
BL, yes; Week 28, no; n=9 0
BL, no; Week 28, yes; n=9 0
BL, no; Week 28, no; n=9 9
BL, yes; Week 36, yes; n=9 0
BL, yes; Week 36, no; n=9 0
BL, no; Week 36, yes; n=9 0
BL, no; Week 36, no; n=9 9
BL, yes; Week 48, yes; n=7 0
BL, yes; Week 48, no; n=7 0
BL, no; Week 48, yes; n=7 0
BL, no; Week 48, no; n=7 7
28.Secondary Outcome
Title Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
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.
Time Frame Baseline and Weeks 8, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: g/L
IgA, Week 8, n=9 0.014  (0.1337)
IgA, Week 24, n=9 -0.023  (0.0865)
IgA, Week 48, n=7 0.086  (0.2889)
IgG, Week 8, n=9 0.647  (0.9004)
IgG, Week 24, n=10 -0.150  (0.8641)
IgG, Week 48, n=7 -0.587  (0.9680)
IgM, Week 8, n=7 -0.063  (0.1482)
IgM, Week 24, n=8 -0.058  (0.1831)
IgM, Week 48, n=5 -0.108  (0.1809)
29.Secondary Outcome
Title Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48
Hide Description HAHA are indicators of immunogenicity to ofatumumab.
Time Frame Screening; Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Positive at Screening, n=10 0
Negative at Screening, n=10 10
Positive at Week 24, n=10 0
Negative at Week 24, n=10 10
Positive at Week 48, n=7 0
Negative at Week 48, n=7 7
30.Secondary Outcome
Title Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Hide Description ECOG PS is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. The grades for the scale range from 0 (fully active) to 4 (completely disabled), with increasing severity.
Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Week 1, improved; n=10 0
Week 1, deteriorated; n=10 0
Week 2, improved; n=10 0
Week 2, deteriorated; n=10 0
Week 3, improved; n=10 0
Week 3, deteriorated; n=10 0
Week 4, improved; n=10 0
Week 4, deteriorated; n=10 0
Week 5, improved; n=10 0
Week 5, deteriorated; n=10 0
Week 6, improved; n=10 0
Week 6, deteriorated; n=10 0
Week 7, improved; n=10 0
Week 7, deteriorated; n=10 0
Week 8, improved; n=10 0
Week 8, deteriorated; n=10 0
Week 12, improved; n=10 0
Week 12, deteriorated; n=10 0
Week 16, improved; n=10 0
Week 16, deteriorated; n=10 0
Week 20, improved; n=10 0
Week 20, deteriorated; n=10 0
Week 24, improved; n=10 0
Week 24, deteriorated; n=10 0
Week 28, improved; n=9 0
Week 28, deteriorated; n=9 0
Week 36, improved; n=9 0
Week 36, deteriorated; n=9 0
Week 48, improved; n=7 0
Week 48, deteriorated; n=7 0
31.Secondary Outcome
Title Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab
Hide Description Blood sampling on Day 1 and at Weeks 7 and 24 for pharmacokinetic (PK) evaluation was performed at the following time points: 0.5 hour (hr) before infusion; end of infusion; and 10 minutes (min), 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
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Hide Analysis Population Description
PK Parameter Population: all participants who received at least one dose of investigational drug, and in whom PK data were available and allowed parameter estimations. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: Micrograms per milliliter (mcg/mL)
Day 1, n=8
69.33
(43.15 to 111.39)
Week 7, n=8
1670.36
(1324.95 to 2105.81)
Week 24, n=7
864.93
(658.73 to 1135.69)
32.Secondary Outcome
Title Minimum Plasma Concentration (Cmin) of Ofatumumab
Hide Description Blood sampling at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
Week 7
832.17
(539.95 to 1282.55)
Week 24
122.08
(28.75 to 518.37)
33.Secondary Outcome
Title Time to Reach Cmax (Tmax) Following Ofatumumab Administration
Hide Description Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: hr
Day 1, n=8
7.208
(6.00 to 16.50)
Week 7, n=8
5.225
(4.47 to 6.30)
Week 24, n=7
5.250
(4.00 to 28.65)
34.Secondary Outcome
Title Half-life (t1/2) of Ofatumumab
Hide Description t1/2 of ofatumumab is the time required for the plasma concentration of ofatumumab to decrease by half. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr
Day 1, n=8
9.585
(5.039 to 18.232)
Week 7, n=8
331.275
(223.561 to 490.886)
Week 24, n=7
300.354
(182.417 to 494.539)
35.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab
Hide Description AUC(0-t) was evaluated from the plasma concentration versus time curve from time zero to the last measurable time point (time t). Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*mcg/mL
Day 1, n=8
1345.1
(466.0 to 3882.6)
Week 7, n=8
587711.3
(332243.3 to 1039613.6)
Week 24, n=7
283751.4
(106203.6 to 758118.2)
36.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7
Hide Description Blood sampling at Week 7 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*mcg/mL
200181.8
(139285.0 to 287703.4)
37.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24
Hide Description Blood sampling at Week 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*mcg/mL
216678.1
(114237.9 to 410979.2)
38.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab
Hide Description Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*mcg/mL
Day 1, n=8
1506.3
(594.0 to 3820.0)
Week 7, n=8
716924.6
(374533.0 to 1372324.7)
Week 24, n=7
302326.7
(122602.4 to 745511.3)
39.Secondary Outcome
Title Clearance (CL) of Ofatumumab From Plasma
Hide Description CL of ofatumumab from plasma of participants was evaluated. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/hr
Day 1, n=8
199.157
(78.535 to 505.042)
Week 7, n=8
9.991
(6.952 to 14.359)
Week 24, n=7
9.230
(4.866 to 17.507)
40.Secondary Outcome
Title Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab
Hide Description Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL
Day 1, n=8
2754.1
(1919.2 to 3952.2)
Week 7, n=8
4774.9
(3610.7 to 6314.5)
Week 24, n=7
3999.7
(2903.1 to 5510.4)
41.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) for Ofatumumab
Hide Description Vss for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body in equilibrium conditions to steady-state plasma concentrations. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL
Day 1, n=8
3667.9
(2324.6 to 5787.5)
Week 7, n=8
1333.8
(928.7 to 1915.4)
Week 24, n=7
3069.2
(2122.9 to 4437.2)
42.Secondary Outcome
Title Mean Residence Time (MRTinf) of Ofatumumab
Hide Description MRTinf is the average amount of time that ofatumumab spends in the body. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Time Frame Day 1; Weeks 7 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr
Day 1, n=8
18.417
(10.437 to 32.500)
Week 7, n=8
478.105
(333.067 to 686.300)
Week 24, n=7
463.945
(263.535 to 816.762)
43.Other Pre-specified Outcome
Title Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50
Hide Description The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it's is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation.
Time Frame Weeks 36 and 48
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Hide Analysis Population Description
All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Arm/Group Title Ofatumumab
Hide Arm/Group Description:
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Kilo units per liter (KU/L)
Week 36, n=8 45.14  (13.643)
Week 48, n=7 53.70  (11.818)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ofatumumab
Hide Arm/Group Description Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
All-Cause Mortality
Ofatumumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Ofatumumab
Affected / at Risk (%)
Total   1/10 (10.00%) 
Gastrointestinal disorders   
Enteritis † 1  1/10 (10.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ofatumumab
Affected / at Risk (%)
Total   10/10 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia † 1  4/10 (40.00%) 
Leukopenia † 1  3/10 (30.00%) 
Lymphopenia † 1  3/10 (30.00%) 
Anaemia † 1  2/10 (20.00%) 
Thrombocytopenia † 1  2/10 (20.00%) 
Iron deficiency anaemia † 1  1/10 (10.00%) 
Lymph node pain † 1  1/10 (10.00%) 
Cardiac disorders   
Palpitations † 1  1/10 (10.00%) 
Ventricular extrasystoles † 1  1/10 (10.00%) 
Ventricular tachycardia † 1  1/10 (10.00%) 
Ear and labyrinth disorders   
Vertigo positional † 1  2/10 (20.00%) 
Ear pain † 1  1/10 (10.00%) 
Tinnitus † 1  1/10 (10.00%) 
Eye disorders   
Cataract † 1  1/10 (10.00%) 
Conjunctivitis allergic † 1  1/10 (10.00%) 
Gastrointestinal disorders   
Constipation † 1  2/10 (20.00%) 
Diarrhoea † 1  2/10 (20.00%) 
Stomatitis † 1  2/10 (20.00%) 
Abdominal pain lower † 1  1/10 (10.00%) 
Colonic polyp † 1  1/10 (10.00%) 
Gastric ulcer † 1  1/10 (10.00%) 
Gastritis atrophic † 1  1/10 (10.00%) 
Gingival swelling † 1  1/10 (10.00%) 
General disorders   
Fatigue † 1  2/10 (20.00%) 
Pyrexia † 1  2/10 (20.00%) 
Asthenia † 1  1/10 (10.00%) 
Chills † 1  1/10 (10.00%) 
Influenza like illness † 1  1/10 (10.00%) 
Mucosal erosion † 1  1/10 (10.00%) 
Oedema peripheral † 1  1/10 (10.00%) 
Hepatobiliary disorders   
Hepatic function abnormal † 1  1/10 (10.00%) 
Infections and infestations   
Nasopharyngitis † 1  3/10 (30.00%) 
Herpes zoster † 1  2/10 (20.00%) 
Influenza † 1  2/10 (20.00%) 
Gastroenteritis † 1  1/10 (10.00%) 
Oral herpes † 1  1/10 (10.00%) 
Pneumonia † 1  1/10 (10.00%) 
Upper respiratory tract infection † 1  1/10 (10.00%) 
Injury, poisoning and procedural complications   
Infusion related reaction † 1  4/10 (40.00%) 
Procedural complication † 1  1/10 (10.00%) 
Thermal burn † 1  1/10 (10.00%) 
Investigations   
Blood lactate dehydrogenase increased † 1  5/10 (50.00%) 
Lymphocyte count decreased † 1  3/10 (30.00%) 
White blood cell count decreased † 1  3/10 (30.00%) 
Aspartate aminotransferase increased † 1  2/10 (20.00%) 
Blood glucose increased † 1  2/10 (20.00%) 
Neutrophil count decreased † 1  2/10 (20.00%) 
Platelet count decreased † 1  2/10 (20.00%) 
Protein total decreased † 1  2/10 (20.00%) 
Alanine aminotransferase increased † 1  1/10 (10.00%) 
Blood albumin decreased † 1  1/10 (10.00%) 
Blood potassium decreased † 1  1/10 (10.00%) 
Blood potassium increased † 1  1/10 (10.00%) 
Blood urea increased † 1  1/10 (10.00%) 
Blood uric acid increased † 1  1/10 (10.00%) 
Electrocardiogram QT prolonged † 1  1/10 (10.00%) 
Gamma-glutamyltransferase increased † 1  1/10 (10.00%) 
Weight increased † 1  1/10 (10.00%) 
Metabolism and nutrition disorders   
Hyperglycaemia † 1  2/10 (20.00%) 
Decreased appetite † 1  1/10 (10.00%) 
Electrolyte imbalance † 1  1/10 (10.00%) 
Hypoglycaemia † 1  1/10 (10.00%) 
Tumour lysis syndrome † 1  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders   
Arthritis † 1  1/10 (10.00%) 
Back pain † 1  1/10 (10.00%) 
Muscular weakness † 1  1/10 (10.00%) 
Musculoskeletal pain † 1  1/10 (10.00%) 
Osteoarthritis † 1  1/10 (10.00%) 
Nervous system disorders   
Peripheral sensory neuropathy † 1  3/10 (30.00%) 
Burning sensation † 1  1/10 (10.00%) 
Dizziness † 1  1/10 (10.00%) 
Dysaesthesia † 1  1/10 (10.00%) 
Dysgeusia † 1  1/10 (10.00%) 
Headache † 1  1/10 (10.00%) 
Hypoaesthesia † 1  1/10 (10.00%) 
Tremor † 1  1/10 (10.00%) 
Psychiatric disorders   
Insomnia † 1  1/10 (10.00%) 
Renal and urinary disorders   
Dysuria † 1  1/10 (10.00%) 
Pollakiuria † 1  1/10 (10.00%) 
Renal impairment † 1  1/10 (10.00%) 
Reproductive system and breast disorders   
Vaginal haemorrhage † 1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea † 1  1/10 (10.00%) 
Dyspnoea exertional † 1  1/10 (10.00%) 
Pleural effusion † 1  1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
Rash † 1  5/10 (50.00%) 
Eczema † 1  2/10 (20.00%) 
Rash pruritic † 1  1/10 (10.00%) 
Vascular disorders   
Hypotension † 1  1/10 (10.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[Not Specified]
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01077622    
Other Study ID Numbers: 112758
First Submitted: February 25, 2010
First Posted: March 1, 2010
Results First Submitted: December 21, 2011
Results First Posted: January 27, 2012
Last Update Posted: May 30, 2017