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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
Roche Pharma AG
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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)
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
You may not be 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
Clareo Health | 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)
