Conditions: Non-Hodgkin's Lymphoma
Keywords: NHL Follicular NHL Rituxan Apo2L/TRAIL
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 72
Healthy volunteers: no

Brief summary:
This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of dulanermin when combined with rituximab in subjects with follicular, CD20+, B-cell Non-Hodgkin's Lymphoma (NHL) that has progressed following a response of ≥ 6 months duration to a prior rituximab-containing therapy. The multicenter, international, randomized Phase II part of this study will commence only after the safety and available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the Sponsor and have been provided to participating investigators and the FDA.

Detailed description:

Arms:
arm 1: Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses. arm 2: Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses. arm 3: Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses. arm 4: Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses. arm 5: Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.

Interventions: intervention 1: Dulanermin intervention 2: Rituximab
Intervention descriptions: intervention 1: Dulanermin was administered by intravenous (IV) infusion over 1 hour on days 1-5 of each 21-day cycle. intervention 2: Rituximab was administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.

Protocol document: