Overview

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

Summary

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
Arm
(Active Comparator)
bendamustine
Intravenous repeating dose
(Experimental)
ro5072759
Intravenous repeating dose
bendamustine
Intravenous repeating dose

Primary Outcomes

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

Secondary Outcomes

Measure
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..