APO2L/TRAIL in Combination With Rituximab in Subjects Non-Hodgkin's Lymphoma
A Study of APO2L/TRAIL in Combination With Rituximab as a potential treatment in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas
Genentech
105 participants
Apr 15, 2006
Interventional
Conditions
Summary
This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of Apo2L/TRAIL when combined with rituximab in subjects with follicular, CD20+, B-cell 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.
Eligibility
Plain Language Summary
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Interventions
Subjects will recieve Rituximab administered by IV infusion at 375 mg/m2 weekly for up to eight doses. Subjects randomized to the combination arm will also receive a maximum of four 21-day 8.0 mg/kg/day cycles of Apo2L/TRAIL (recombinant human Apo2 ligand/tumor necrosis factor-related apoptosis-inducing ligand), by IV infusion.
Locations(2)
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ACTRN12608000627358