Clinical Trial ECOG 1412
- Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma
- Principal Investigator
- Jason Kaplan
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 1412
- The purpose of this study is to find out what effects, good and/or bad, the addition of lenalidomide (also called revlimid) to standard chemotherapy (RCHOP - Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) has on patients and their cancer.
- Everybody in this study will receive standard chemotherapy. In addition to standard chemotherapy, half of the patients will receive a medication called lenalidomide. Adding lenalidomide to the standard chemotherapy RCHOP is considered experimental in diffuse large B cell lymphoma, and is not FDA approved for this disease (though it is FDA approved for a different type of B cell lymphoma).
Some of the eligibility criteria include:
- Participants must have a diagnosis of diffuse large B-cell lymphoma that is CD20 positive.
- Participants may not have received prior treatment for their cancer.
- Participants must be 18 or older.
- Description of Treatment
- Study participants will receive up to 6 cycles of chemotherapy, with each cycle given 21 days apart. Those in group 1 (Arm A) will receive rituximab, cyclophosphamide, doxorubicin, and vincristine as an intravenous infusion (IV) on day 1 of the cycle, and prednisone orally on day 1 to 5 of each cycle (this combination is called RCHOP). In addition, participants in this group will receive lenalidomide by mouth for 10 days of each cycle. This treatment will be repeated every 21 days. Participants assigned to group 2 (Arm B) will also receive identical RCHOP treatment, on the same schedule, but will not receive lenalidomide.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumor and Lymphoma Malignancies
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- A Phase 1B, Multi-Center, Open Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B cell Lymphoma and Follicular Lymphoma
- A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies
- Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies
- A Phase II Clinical Trial Evaluating Ibrutinib Maintenance Following Intensive Induction for Patients with Previously Untreated Mantle Cell Lymphoma (MCL)
last updated: 11-Dec-16 03:57 AM
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