A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)

Completed · Phase 1

Conditions studied: Lymphocytic Leukemia, Chronic

In brief

This open-label, 2-arm, nonrandomized, multicenter, Phase Ib study will investigate the safety and efficacy of obinutuzumab (RO5072759; GA101) administered in combination with chemotherapy (bendamustine or fludarabine + cyclophosphamide \[FC\] regimens) in participants with previously untreated cluster of differentiation 20 (CD20)-positive B-CLL. Participants will be enrolled to receive a maximum of 6 cycles of obinutuzumab (1000 milligrams \[mg\] intravenous \[IV\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus bendamustine (90 milligrams per meter square \[mg/m\^2\] IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 - 6) plus FC (fludarabine 25 mg/m\^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2 - 6; cyclophosphamide 250 mg/m\^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2 - 6) on 28 day cycles.

Key facts

Study ID: NCT01300247
Run by: Genentech, Inc.
People needed: 41
Starts: 2011-05-01
Expected to finish: 2015-12-01
Last updated by the study team: 2017-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Confirmed diagnosis of CD20-positive B-CLL
Rai Stage III/IV or Binet Stage C disease
Rai Stage I/II or Binet Stage B disease that requires treatment
Adequate baseline bone marrow function, unless there is clear evidence of extensive bone marrow involvement with tumor infiltration, myelodysplasia, or hypocellularity
No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Life expectancy of greater than (>) 6 months

You may not qualify if…

Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
Transformation of CLL to aggressive B-cell malignancy
Creatinine clearance less than equal to (<=) 60 milliliters per minute (mL/min), calculated according to the formula of Cockcroft and Gault
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN)
Total bilirubin greater than equal to (>=) 3 x ULN
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
History of sensitivity to mannitol (if bendamustine is to be administered)
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
Known infection with human immunodeficiency virus (HIV) seropositive status
Presence of positive test results for hepatitis B (hepatitis B virus [HBV] surface antigen [HBsAg] and/or total hepatitis B core antibody [anti-HBc]) or hepatitis C (hepatitis C virus [HCV] antibody serology testing). Participants with chronic HBV infection, occult HBV infection, or past HBV infection will be excluded. Participants who have received IV immunoglobulin within 3 months of enrollment and who are anti-HBc positive but HBV deoxyribonucleic acid (DNA) negative will be considered for inclusion on the study by the Medical Monitor on a case-by-case basis. Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
Women who are pregnant or lactating
Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Concurrent (or within 7 days prior to the first dose of study treatment) systemic corticosteroid use except low-dose corticosteroid therapy used to treat an illness other than lymphoma

Where it is running

Study site — Huntsville, Alabama, United States
Study site — Duarte, California, United States
Study site — La Jolla, California, United States
Study site — Los Angeles, California, United States
Study site — Southington, Connecticut, United States
Study site — Tampa, Florida, United States
Study site — Atlanta, Georgia, United States
Study site — Marietta, Georgia, United States
Study site — Chicago, Illinois, United States
Study site — Boston, Maryland, United States
Study site — Boston, Massachusetts, United States
Study site — Saint Louis Park, Minnesota, United States
Study site — Springfield, Missouri, United States
Study site — Rochester, New York, United States
Study site — Houston, Texas, United States
Study site — Seattle, Washington, United States
Study site — Tacoma, Washington, United States
Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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