ActivePhase 2ACTRN12608000554369

A Study of Apomab in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy

A Phase II, Single-Arm, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of Multiple Doses of Apomab Administered Intravenously in Combination With Rituximab in Patients With Follicular, CD20-Positive B-Cell Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy


Sponsor

Genentech, Inc

Enrollment

50 participants

Start Date

Aug 1, 2007

Study Type

Interventional

Conditions

Summary

Apomab is a monoclonal antibody, which is a type of protein that is normally made by the immune system to help defend the body from infection and cancer. In preclinical studies Apomab selectively induced programmed cell death, or apoptosis, in cancer cells while sparing normal cells. Apomab is being studied in this clinical trial in combination with Rituximab to evaluate whether it is safe for patients with follicular NHL and whether it can delay the further spread of follicular NHL.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests an experimental antibody treatment (Apomab) combined with rituximab for adults aged 18 and older with a type of non-Hodgkin's lymphoma (follicular lymphoma) that has progressed after previous rituximab treatment. Participants must have measurable disease, a life expectancy of more than 3 months, and no prior treatment with similar experimental antibodies.

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

All patients will receive Rituximab once per week for up to 8 weeks in Cycles 1-3. The first dose of Rituximab will be administered between 24 and 120 hours prior to the first dose of Apomab in Cycle

All patients will receive Rituximab once per week for up to 8 weeks in Cycles 1-3. The first dose of Rituximab will be administered between 24 and 120 hours prior to the first dose of Apomab in Cycle 1. In Cycles 2 & 3 on Day 1, Rituximab will be administered directly prior to Apomab, without a rest period between the two treatments. All patients will receive Apomab for a total of six cycles. Each cycle lasts 21 days with a resting period built into each cycle. The length of the resting period depends on the cycle. The Apomab dose will be based on the patient's body weight at screening. The rituximab dose will be based on the patient's body surface area at screening. Both Rituximab and Apomab are administered intravenously (IV).


Locations(7)

United Kingdom

Spain

United States of America

Netherlands

Belgium

Switzerland

Russian Federation

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ACTRN12608000554369