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A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01680991
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular Lymphoma
Intervention Drug: Obinutuzumab
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg. Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Period Title: Overall Study
Started 12 23 13
Completed 4 4 9
Not Completed 8 19 4
Reason Not Completed
Adverse Event             1             0             0
Death             1             0             1
Protocol Violation             0             1             0
Withdrawal by Subject             5             1             0
Progressive disease (PD)             0             10             0
Physician Decision             0             7             2
Bad physical condition             0             0             1
PD confirmed in other hospital             1             0             0
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab Total
Hide Arm/Group Description Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg. Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. Total of all reporting groups
Overall Number of Baseline Participants 12 23 13 48
Hide Baseline Analysis Population Description
Safety analysis population included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 23 participants 13 participants 48 participants
60.7  (12.0) 53.3  (15.8) 55.1  (8.8) 55.6  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 23 participants 13 participants 48 participants
Female
5
  41.7%
12
  52.2%
5
  38.5%
22
  45.8%
Male
7
  58.3%
11
  47.8%
8
  61.5%
26
  54.2%
1.Primary Outcome
Title Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1
Hide Description DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.
Time Frame Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who received at least 1 dose of study drug and had serum concentrations available. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 11 21 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day*micrograms per milliliter
1458
(34.8%)
1750
(20.5%)
1647
(20.7%)
2.Primary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1
Hide Description DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.
Time Frame Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 11 21 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (mcg/mL)
369
(31.8%)
442
(21.1%)
437
(16.7%)
3.Primary Outcome
Title Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8
Hide Description [Not Specified]
Time Frame Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 9 8 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day*mcg/mL
12289
(42.7%)
13000
(37.3%)
11285
(26.7%)
4.Primary Outcome
Title Cmax of Obinutuzumab at Cycle 8
Hide Description [Not Specified]
Time Frame Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 9 8 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
1050
(32.6%)
966
(28.3%)
867
(19.6%)
5.Secondary Outcome
Title Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8
Hide Description [Not Specified]
Time Frame Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 9 8 11
Median (Full Range)
Unit of Measure: hours
3.5
(3.3 to 25.5)
7.25
(3.3 to 27.5)
4.0
(3.2 to 7.8)
6.Secondary Outcome
Title Apparent Terminal Half-life (t1/2)
Hide Description Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.
Time Frame Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 9 6 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day
21.5
(71.8%)
33.3
(68.6%)
26.7
(49.6%)
7.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8
Hide Description Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.
Time Frame Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 9 6 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
3.32
(27.9%)
4.49
(38.2%)
4.03
(21.5%)
8.Secondary Outcome
Title Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time Frame Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 9 8 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/day
81.4
(42.7%)
76.9
(37.3%)
88.6
(26.7%)
9.Secondary Outcome
Title Minimum Observed Serum Concentration of Obinutuzumab
Hide Description [Not Specified]
Time Frame Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" is the number of participants evaluable at the specified time point.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 11 22 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
Cycle 1-Day 8 (n=11,22,13)
156
(57.2%)
186
(25.2%)
148
(39.2%)
Cycle 1-Day 15 (n=11,22,13)
282
(69.4%)
350
(23.7%)
284
(26.5%)
Cycle 2 (n=11,21,13)
389
(71.2%)
458
(26.3%)
433
(31.2%)
Cycle 3 (n=10,18,13)
260
(246%)
367
(49.6%)
346
(31%)
Cycle 4 (n=10,14,13)
232
(279.7%)
370
(49.2%)
346
(31%)
Cycle 5 (n=9,11,11)
299
(91.2%)
412
(42%)
396
(44.8%)
Cycle 6 (n=9,10,11)
317
(93.5%)
425
(38.2%)
361
(40.6%)
Cycle 7 (n=9,10,11)
358
(80.6%)
367
(40.3%)
375
(41.3%)
Cycle 8 (n=9,8,11)
403
(85.3%)
455
(45.4%)
352
(38.4%)
10.Secondary Outcome
Title Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria
Hide Description CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (>) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).
Time Frame 1 month after the last dose (received on Day 148) of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Data reported only for DLBCL and FL arm groups.
Arm/Group Title DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 23 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
0
(0.00 to 14.82)
0
(0.00 to 24.71)
CRu
4.3
(0.11 to 21.95)
0
(0.00 to 24.71)
11.Secondary Outcome
Title Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria
Hide Description PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.
Time Frame 1 month after the last dose (received on Day 148) of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Data reported only for DLBCL and FL arm groups.
Arm/Group Title DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 23 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PR
8.7
(1.07 to 28.04)
46.2
(19.22 to 74.87)
SD
8.7
(1.07 to 28.04)
30.8
(9.09 to 61.43)
PD
65.2
(42.73 to 83.62)
23.1
(5.04 to 53.81)
12.Secondary Outcome
Title Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria
Hide Description CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN >1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).
Time Frame From screening to up to 1 month after the last dose (received on Day 148) of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Data reported only for DLBCL and FL arm groups.
Arm/Group Title DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 23 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
0
(0.00 to 14.82)
0
(0.00 to 24.71)
CRu
4.3
(0.11 to 21.95)
0
(0.00 to 24.71)
13.Secondary Outcome
Title Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria
Hide Description PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.
Time Frame From screening to up to 1 month after the last dose (received on Day 148) of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Data reported only for DLBCL and FL arm groups.
Arm/Group Title DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 23 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PR
21.7
(7.46 to 43.70)
61.5
(31.58 to 86.14)
SD
26.1
(10.23 to 48.41)
30.8
(9.09 to 61.43)
PD
39.1
(19.71 to 61.46)
7.7
(0.19 to 36.03)
14.Secondary Outcome
Title Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines
Hide Description CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (<) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] >1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) >100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) >11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.
Time Frame 2 months after the last dose (received on Day 148) of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Data reported only for CLL participants.
Arm/Group Title CLL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CRe
0
(0.00 to 26.46)
CRi
0
(0.00 to 26.46)
15.Secondary Outcome
Title Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines
Hide Description Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.
Time Frame 2 months after the last dose (received on Day 148) of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Data reported only for CLL participants
Arm/Group Title CLL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PR
58.3
(27.67 to 84.83)
SD
8.3
(0.21 to 38.48)
PD
16.7
(2.09 to 48.41)
16.Secondary Outcome
Title Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines
Hide Description CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL <4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu >1.5 x 10^9/L without the need for EGF, ii. Plt >100 x 10^9/L without the need for EGF, and iii. Hb >11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.
Time Frame From screening to up to 2 months after the last dose (received on Day 148) of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Data reported only for CLL participants.
Arm/Group Title CLL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CRe
0
(0.00 to 26.46)
CRi
0
(0.00 to 26.46)
17.Secondary Outcome
Title Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines
Hide Description Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.
Time Frame From screening to up to 2 months after the last dose (received on Day 148) of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Data reported only for CLL participants.
Arm/Group Title CLL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PR
75.0
(42.81 to 94.51)
SD
8.3
(0.21 to 38.48)
PD
0
(0.00 to 26.46)
18.Secondary Outcome
Title Number of Participants With Positive Human Anti-Human Antibodies (HAHA)
Hide Description For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.
Time Frame Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. "n" represents the number of participants who were evaluable at the specified time point.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 12 23 13
Measure Type: Number
Unit of Measure: participants
Cycle 1, Day 1 (n=12,23,13) 0 0 0
Cycle 4, Day 1 (n=11,14,13) 0 0 0
4 week follow-up (n=10,10,11) 0 0 0
3 month follow-up (n=8,4,11) 0 0 0
6 month follow-up (n=7,4,11) 0 0 1
19.Secondary Outcome
Title Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)
Hide Description Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.
Time Frame Cycle 1, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 10 20 7
Measure Type: Number
Unit of Measure: participants
2 1 0
20.Secondary Outcome
Title Number of Participants With B-cell Depletion or Recovery
Hide Description Depletion is defined as cluster of differentiation (CD) 19+ B-cell count <0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.
Time Frame Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 12 23 13
Measure Type: Number
Unit of Measure: participants
B-cell Depletion 9 23 13
B-cell Recovery 4 1 1
21.Secondary Outcome
Title Duration of Depletion of CD19+ B-cell
Hide Description Depletion is defined as CD19+ B-cell count < 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.
Time Frame Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 9 23 12
Mean (Standard Deviation)
Unit of Measure: days
238.7  (182.5) 141.0  (167.5) 386.0  (176.0)
22.Secondary Outcome
Title Time to Recovery of CD19+ B-cell
Hide Description Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.
Time Frame Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" represents the number of participants evaluable for the specified category.
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description:
Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Number of Participants Analyzed 4 1 1
Mean (Standard Deviation)
Unit of Measure: days
Time to recovery with PD (n=1,0,1) 419 [1]   (NA) NA [2]   (NA) 331.0 [1]   (NA)
Time to recovery without PD (n=3,1,0) 229.0  (87.5) 515.0 [1]   (NA) NA [2]   (NA)
[1]
Standard deviation is not applicable as data of a single participant is reported.
[2]
No participant experienced B-cell recovery for this category.
Time Frame Until 3 months after last study drug (Up to approximately 9 months)
Adverse Event Reporting Description Safety analysis population.
 
Arm/Group Title CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Hide Arm/Group Description Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg. Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
All-Cause Mortality
CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/12 (41.67%)   3/23 (13.04%)   1/13 (7.69%) 
Blood and lymphatic system disorders       
Neutropenia * 1  1/12 (8.33%)  0/23 (0.00%)  1/13 (7.69%) 
Thrombocytopenia * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
General disorders       
Submandibular mass * 1  0/12 (0.00%)  1/23 (4.35%)  0/13 (0.00%) 
Infections and infestations       
Pneumonia * 1  2/12 (16.67%)  0/23 (0.00%)  1/13 (7.69%) 
Infected cyst * 1  0/12 (0.00%)  1/23 (4.35%)  0/13 (0.00%) 
Urinary tract infection * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Investigations       
Platelet count decreased * 1  0/12 (0.00%)  1/23 (4.35%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial lung disease * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CLL: 1000 mg Obinutuzumab DLBCL: 1000 mg Obinutuzumab FL: 1000 mg Obinutuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/12 (83.33%)   17/23 (73.91%)   7/13 (53.85%) 
Blood and lymphatic system disorders       
Anaemia * 1  2/12 (16.67%)  0/23 (0.00%)  1/13 (7.69%) 
Thrombocytopenia * 1  2/12 (16.67%)  1/23 (4.35%)  0/13 (0.00%) 
Lymph node pain * 1  1/12 (8.33%)  1/23 (4.35%)  0/13 (0.00%) 
Leukocytosis * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Leukopenia * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Neutropenia * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Eye disorders       
Scleral haemorrhage * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  0/12 (0.00%)  2/23 (8.70%)  0/13 (0.00%) 
Diarrhoea * 1  1/12 (8.33%)  0/23 (0.00%)  1/13 (7.69%) 
Nausea * 1  1/12 (8.33%)  1/23 (4.35%)  0/13 (0.00%) 
Vomiting * 1  0/12 (0.00%)  1/23 (4.35%)  1/13 (7.69%) 
Dyspepsia * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Toothache * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
General disorders       
Pyrexia * 1  6/12 (50.00%)  3/23 (13.04%)  2/13 (15.38%) 
Chills * 1  3/12 (25.00%)  1/23 (4.35%)  0/13 (0.00%) 
Chest discomfort * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Local swelling * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Infections and infestations       
Nasopharyngitis * 1  0/12 (0.00%)  2/23 (8.70%)  0/13 (0.00%) 
Epididymitis * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Gingivitis * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Herpes zoster * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Influenza * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Urinary tract infection * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Injury, poisoning and procedural complications       
Infusion related reaction * 1  7/12 (58.33%)  5/23 (21.74%)  3/13 (23.08%) 
Scratch * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  0/12 (0.00%)  3/23 (13.04%)  0/13 (0.00%) 
Aspartate aminotransferase increased * 1  0/12 (0.00%)  3/23 (13.04%)  0/13 (0.00%) 
Blood creatinine increased * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Blood pressure decreased * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Blood uric acid increased * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Heart rate decreased * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Neutrophil count decreased * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Platelet count decreased * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
White blood cell count decreased * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity * 1  1/12 (8.33%)  1/23 (4.35%)  0/13 (0.00%) 
Muscular weakness * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Nervous system disorders       
Tremor * 1  1/12 (8.33%)  1/23 (4.35%)  0/13 (0.00%) 
Extrapyramidal disorder * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Psychiatric disorders       
Insomnia * 1  1/12 (8.33%)  1/23 (4.35%)  0/13 (0.00%) 
Renal and urinary disorders       
Urinary retention * 1  1/12 (8.33%)  0/23 (0.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  4/12 (33.33%)  1/23 (4.35%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  0/12 (0.00%)  1/23 (4.35%)  1/13 (7.69%) 
Rash * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
Vascular disorders       
Hypertension * 1  2/12 (16.67%)  1/23 (4.35%)  0/13 (0.00%) 
Deep vein thrombosis * 1  0/12 (0.00%)  0/23 (0.00%)  1/13 (7.69%) 
*
Indicates events were collected by non-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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01680991    
Other Study ID Numbers: YP25623
First Submitted: September 4, 2012
First Posted: September 7, 2012
Results First Submitted: March 23, 2016
Results First Posted: April 25, 2016
Last Update Posted: April 25, 2016