A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

Completed · Phase 3

Conditions studied: Non-Hodgkin's Lymphoma

In brief

This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).

Key facts

Study ID

NCT01059630

Run by

Genentech, Inc.

People needed

413

Starts

2010-04-30

Expected to finish

2018-11-30

Last updated by the study team

2020-01-13

Who can join

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

You may qualify if…

• History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL
• Refractory to any previous regimen containing rituximab (defined by participants who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen)
• Previously treated with a maximum of four unique chemotherapy containing treatment regimens
• All participants must have at least one bi-dimensionally measurable lesion (greater than [>]1.5 centimeters (cm) in its largest dimension by computed tomography [CT] scan)

You may not qualify if…

• Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to the start of Cycle 1, prior treatment with obinutuzumab was not allowed
• Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
• Prior treatment with bendamustine (within 2 years of the start of Cycle 1)
• Prior allogeneic stem cell transplant
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• History of sensitivity to mannitol
• Central nervous system lymphoma or prior diffuse large B-cell lymphoma (DLBCL), histological evidence of transformation to high grade or diffuse large B-cell lymphoma
• 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
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
• Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
• Vaccination with a live vaccine a minimum of 28 days prior to randomization
• Recent major surgery (within 4 weeks), other than for diagnosis
• Presence of positive test results for Hepatitis B surface antigen (HBsAg); antibody to hepatitis B core antigen [anti-HBc]) with detectable viral load (positive hepatitis B virus [HBV] deoxyribo-nucleic acid [DNA]) or Hepatitis C
• Participants with chronic hepatitis B or seropositive occult (HBV) infection
• Participants with seronegative occult HBV infection or past HBV infection (defined as anti-HBc positive and HBV DNA negative) could be eligible if they were willing to be followed according to the protocol for HBV DNA testing
• Participants positive for Hepatitis C virus (HCV) antibody were eligible only if polymerase chain reaction(PCR) was negative for HCV Ribonucleic acid (RNA)
• Known history of human immunodeficiency virus (HIV) seropositive status
• Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries
• 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
• Ongoing corticosteroid use >30 milligrams per day (mg/day) prednisone or equivalent

Where it is running

• Dr. Donald W. Hill, MD, FACP — Casa Grande, Arizona, United States
• Highlands Oncology Group — Rogers, Arkansas, United States
• Kaiser Permanente - Bellflower — Bellflower, California, United States
• Bay Area Cancer Research Group, LLC — Pleasant Hill, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Washington DC VA Med Center; Hematology — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• University of Florida; Division of Hematology/Oncology — Gainesville, Florida, United States
• Md Anderson Cancer Center Orlando — Orlando, Florida, United States
• Rush Cancer Institute — Chicago, Illinois, United States
• Quincy Medical Group — Quincy, Illinois, United States
• Simmons Cancer Institute — Springfield, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Univ Louisville School of Med — Louisville, Kentucky, United States
• New England Cancer Specialists — Scarborough, Maine, United States
• Meritus Center for Clinical Research — Hagerstown, Maryland, United States
• Capitol Comprehensive CA Care — Jefferson City, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Hematology Oncology Assoc SJ — Mount Holly, New Jersey, United States
• San Juan Oncology — Farmington, New Mexico, United States
• The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. — Columbus, Ohio, United States
• OHSU Knight Cancer Institute — Portland, Oregon, United States
• Pacific Oncology, PC — Portland, Oregon, United States
• Southern Cancer Center, PC — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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