Clinical Trial Detail

This is an open-label, multicenter, randomized, Phase III study to investigate the efficacy and safety of GA101 combined with bendamustine compared with bendamustine alone in patients with rituximab-refractory, indolent Non-Hodgkin's lymphoma (NHL).

Ages Eligible for Study: 18 Years and older

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.

- 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 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.