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Complete 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-Hodgkins lymphoma
|Research Study Number||2388.00|
|Principal Investigator||Oliver Press, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- History of histologically documented, CD20+, indolent NHL
- Refractory to any previous regimen containing rituximab
- Previously treated with a maximum of three 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)
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Chemotherapy or other investigational therapy within 28 days
- Prior treatment with bendamustine within 1 year
- 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
Other exclusion criteria may apply.
Hematologic Malignancies; Lymphoma; Non-Hodgkin's Lymphoma (NHL)
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