A Study of Dulanermin in Combination With Rituximab in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas

Sponsor
Genentech, Inc.
Study ID
NCT00400764
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2006
Status verified
Nov 2011
Primary completion
May 31, 2010

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib: Dulanermin 4 mg/kg
    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.
  • Experimental: Phase Ib: Dulanermin 8 mg/kg
    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.
  • Active Comparator: Phase II: Rituximab
    Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
  • Experimental: Phase II: Combination Therapy
    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.
  • Experimental: Phase II: Dulanermin
    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.

Primary Outcome Measure

Phase Ib: Number of Participants With a Dose-limiting Toxicity [ Time Frame: The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28). ]

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