This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatments ro5072759, bendamustine
Phase phase 3
Target CD20
Sponsor Genentech, Inc.
Collaborator Roche Pharma AG
Start date April 2010
End date September 2014
Trial size 414 participants
Trial identifier NCT01059630, GAO4753g, GO01297


This open-label, multicenter, randomized, Phase III study will investigate the efficacy and safety of RO5072759 (GA101) combined with bendamustine compared with bendamustine alone in patients with rituximab-refractory, indolent Non-Hodgkin's lymphoma (NHL). Patients will be randomized to receive a maximum of 6 cycles of GA101 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2 - 6) and then every 2 months until disease progression for up to 2 years plus bendamustine (90 mg/m2 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 bendamustine alone (120 mg/m2 IV, on days 1 and 2 of cycles 1 - 6) on 28 day cycles.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose

Primary Outcomes

Progression-free survival (PFS)
time frame: Time from randomization to first occurrence of progression or relapse, or death

Secondary Outcomes

Overall survival
time frame: Time from randomization to death
Complete response (CR) and overall response (CR or partial response [PR])
time frame: At 6 months
Best response
time frame: Up to 12 months after start of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - History of histologically documented, CD20+, indolent NHL - Refractory to any previous regimen containing rituximab - Previously treated with a maximum of four unique chemotherapy containing treatment regimens - All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan) Exclusion Criteria: - Prior use of any monoclonal antibody (other than anti-CD20) within 3 months - Chemotherapy or other investigational therapy within 28 days - Prior treatment with bendamustine (within 2 years of the start of study treatment). Patients with prior bendamustine treatment (greater than 2 years prior to the start of study treatment ) are eligible if they meet both of the following criteria: achieved either partial or complete response to the bendamustine regimen of at least 12 months in duration prior to relapse/progression and experienced progression following a regimen containing an alkylating agent - Prior allogeneic stem cell transplant - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (e.g., patients in whom re-dosing with rituximab would be contraindicated for safety reasons) - History of sensitivity to mannitol - Central nervous system lymphoma or 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 - 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 or Hepatitis C - Known history of 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 - Agreement to use an effective form of contraception for the duration of the study - Ongoing corticosteroid use >30 mg/day prednisone or equivalent

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Genentech, Inc..