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)
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/6/2019 |
Start Date: | April 30, 2010 |
End Date: | November 30, 2018 |
An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma
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).
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).
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
We found this trial at
34
sites
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1400 South Orange Avenue
Orlando, Florida 32806
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
Columbus, Ohio 43219
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2000 Southwest Archer Road
Gainesville, Florida 33610
Gainesville, Florida 33610
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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OHSU Knight Cancer Institute OHSU Knight Cancer Institute is known worldwide for our contributions to...
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Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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50 Irving Street Northwest
Washington, District of Columbia 20422
Washington, District of Columbia 20422
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