CALGB 50401: A Randomized Phase II Trial of Rituximab vs. Lenalidomide (Revlimid, CC-5013) (IND #73034) vs. Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) After Relapse from a Rituximab-Containing Regimen

Study Status

Open to Enrollment

Study Description

This phase 2 trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to (unresponsive to) rituximab.

Patients will be randomized to one of the following two treatment arms:
 

  • Arm A:  Lenalidomide Alone The starting dose of lenalidomide will be 15 mg/day PO on days 1-21, followed by 7 days of rest. After cycle 2, the dose will be escalated in patients who have not had therapy delayed and who have recovered from previous toxicity. Maximum dose will be 25 mg/day. In the absence of intolerable toxicity or disease progression, lenalidomide will be given for a total of twelve cycles.
  • Arm B:  Rituximab + Lenalidomide Lenalidomide will be administered the same as stated in Arm A. Rituximab will be administered at a dose of 375 mg/m2 by IV on Days 8, 5, 22 and 29, beginning one week after initiation of lenalidomide. Patients will receive four weekly infusions of rituximab, and twelve cycles of lenalidomide.

Restaging for both arms will be during months 2, 4, 6, 9, 12, 15, 18, and 24, and then yearly until disease progression, or for a maximum of ten years from study entry.

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Disease Status and/or Stage

Recurrent Follicular Non-Hodgkin's Lymphoma

Sponsor

Cancer and Leukemia Group B; National Cancer Institute

Key Eligibility

  • Men and women, age 18 and older
  • Confirmed diagnosis of follicular non-Hodgkin's lymphoma
  • Have been treated with rituximab either alone or in combination with chemotherapy; the last prior treatment need not include rituximab
  • Must have progressed ≥ 6 months from the last dose of rituximab
  • More detailed eligibility discussed when you contact the study team

Principal Investigator

Rebecca Elstrom, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
roh2026@med.cornell.edu

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