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
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