RecruitingPhase 2ACTRN12608000627358

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


Sponsor

Genentech

Enrollment

105 participants

Start Date

Apr 15, 2006

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 0 N/As

Plain Language Summary

Simplified for easier understanding

This study is for people with a type of slow-growing lymphoma called follicular non-Hodgkin's lymphoma (NHL) that has come back after previous treatment with rituximab. The study tests combining a new experimental drug called APO2L/TRAIL with rituximab (a standard lymphoma antibody treatment) to see if together they can better control the lymphoma. APO2L/TRAIL is designed to trigger cancer cell death. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with follicular non-Hodgkin's lymphoma (CD20+, grade 1, 2, or 3a) - Your lymphoma came back or grew after a previous rituximab-containing treatment that had worked for at least 6 months - You have measurable disease on scans - You are generally well (ECOG performance status 0 or 1) - Your life expectancy is more than 3 months - You are using reliable contraception if you could become pregnant You may NOT be eligible if: - You have received chemotherapy or radiation within the last 4 weeks - You are pregnant or breastfeeding - You have HIV, hepatitis B, or hepatitis C - You have significant heart disease - You are currently taking systemic corticosteroids (like prednisone) - You have had another cancer in the last 5 years - You have had prior treatment with APO2L/TRAIL Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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/

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)

1023, New Zealand

8001, New Zealand

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