A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
An Open-label, Multicenter, Randomized Phase II Trial Comparing the Efficacy, Safety, and Pharmacokinetics of GA101 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia
2 other identifiers
interventional
80
1 country
31
Brief Summary
This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous \[IV\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2011
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedStudy Start
First participant enrolled
October 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2013
CompletedResults Posted
Study results publicly available
April 24, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2016
CompletedApril 17, 2017
March 1, 2017
1.4 years
August 10, 2011
March 21, 2014
March 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR) as assessed by the investigator according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines two months after last treatment. CR required: blood lymphocytes \< 4 x 10\^9/Liter (L), absence of lymphadenopathy (≤ 1.5 centimeter (cm) in long axis by Computed Tomography), no hepatomegaly or splenomegaly, absence of disease, Neutrophils \> 1.5 x 10\^9/L, Platelets \> 100 x 10\^9/L, Hemoglobin \>11 g/dL, bone marrow normal and lymphoid nodules absent. CRi was CR with incomplete marrow recovery. PR required: 50% decrease in peripheral blood lymphocyte count, 50% reduction in lymphadenopathy, 50% reduction of liver and/or spleen enlargement if enlarged at baseline, Neutrophils \> 1.5 x 10\^9/L or \> 50% of pretreatment value, Platelets \> 100 x 10\^9/L or 50% of pretreatment value and Hemoglobin \> 11 g/dL or \> 50% of pretreatment value.
Week 32
Secondary Outcomes (14)
Progression-free Survival (PFS)
Up to 4 years, 5 months
Duration of Response
Up to 4 years, 5 months
Number of Participants Surviving at End-of-Study
Up to 4 years, 5 months
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Up to 4 years, 5 months
Percentage of Participants With Adverse Events of Interest
Up to 4 years, 5 months
- +9 more secondary outcomes
Study Arms (2)
Obinutuzumab 1000 mg
EXPERIMENTALParticipants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
Obinutuzumab 2000 mg
EXPERIMENTALParticipants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
Interventions
Participants were administered obinutuzumab either at 1000 mg or 2000 mg on Day 1, 8, 15 of Cycle 1 and then on Day 1 of each 21 day cycles for up to 8 cycles.
Participants were administered corticosteroids IV prior to the initial dose.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of CD20-positive B-cell CLL (per International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] guidelines)
- Rai Stage III/IV or Binet Stage C disease, or Rai Stage I/II or Binet Stage B disease that requires treatment according to IWCLL guidelines
- No previous treatment for CLL chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP); prior use of steroids for AIHA or ITP is allowed
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2
You may not qualify if:
- Confirmed diagnosis of Transformation of CLL to aggressive B-cell malignancy
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Evidence of severe, uncontrolled concomitant disease
- Known active infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before the start of Cycle 1
- Seropositive for human immunodeficiency virus (HIV)
- Positive for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology)
- Positive for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)
- Pregnant or lactating women
- Concurrent (or within 7 days prior to first dose of study treatment) systemic corticosteroid use, except for low-dose corticosteroid therapy used to treat chronic medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (31)
Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr
Birmingham, Alabama, 35291-3300, United States
Arizona Oncology
Tucson, Arizona, 85704, United States
Arizona Clinical Research Ctr
Tucson, Arizona, 85715, United States
University of California; Moores Cancer Center
La Jolla, California, 92093, United States
USC Norris Cancer Center
Los Angeles, California, 90033, United States
USC/Norris Can Ctr; IDS Pharm
Los Angeles, California, 90033, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Wilshire Oncology Medical Group
Pasadena, California, 91750, United States
Univ of Colorado Canc Ctr
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Center; Medical Oncology
Denver, Colorado, 80218, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Goshen Hlth Sys Ctr Can Care
Goshen, Indiana, 46526, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905, United States
Purchase Cancer Group
Paducah, Kentucky, 42001, United States
Hem Onc Assoc of Northern NJ; Carol G. Simon Canc Ctr
Morristown, New Jersey, 07962, United States
Columbia University Medical Center
New York, New York, 10032, United States
Ohio State University
Columbus, Ohio, 43210, United States
Mark H. Zangmeister Center
Columbus, Ohio, 43219, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
INTEGRIS Cancer Inst of OK
Oklahoma City, Oklahoma, 73142, United States
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, 97401-8122, United States
Texas Oncology-Medical City Dallas
Dallas, Texas, 75230, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
US Oncology Research Pharm.
Fort Worth, Texas, 76177, United States
Texas Cancer Center - Sherman
Sherman, Texas, 75090-0504, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
SW Virginia Hem Onc
Roanoke, Virginia, 24014, United States
Shenandoah Oncology Associates
Winchester, Virginia, 22601, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Related Publications (1)
Byrd JC, Flynn JM, Kipps TJ, Boxer M, Kolibaba KS, Carlile DJ, Fingerle-Rowson G, Tyson N, Hirata J, Sharman JP. Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia. Blood. 2016 Jan 7;127(1):79-86. doi: 10.1182/blood-2015-03-634394. Epub 2015 Oct 15.
PMID: 26472752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 11, 2011
Study Start
October 31, 2011
Primary Completion
March 31, 2013
Study Completion
March 31, 2016
Last Updated
April 17, 2017
Results First Posted
April 24, 2014
Record last verified: 2017-03