E1412: 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

Summary

This study is a multicenter randomized phase 2 study of lenalidomide and RCHoP (R2CHoP) vs. RCHoP in patients with newly diagnosed DLBCL to evaluate the efficacy of this combination.

arm a:experimental arm
R2CHoP X 6 cycles
[?] Lenalidomide
[?] Rituximab
[?] Cyclophosphamide
[?] Doxorubicin
[?] Vincristine
[?] Prednisone

arm B:Control arm
RCHoP x 6 cycles
[?] Rituximab
[?] Cyclophosphamide
[?] Doxorubicin
[?] Vincristine
[?] Prednisone

Participant Eligibility

(1) Age >= 18 years.
(2) Histologically confirmed DLBCL expressing CD20 anti-gen. Patients with transform lymphoma are excluded. Patients with known primary mediastinal large B-cell lymphoma (PMLBCL) are excluded because contemporary data suggest patients with this entity may be best served with the dose adjusted EPOCH-R regimen or with R-CHOP followed by consolidative XRT. Similarly, patients with known c-myc translocation (by fluorescence in situ hybridization) positive DLBCL are encouraged to participate trials specifically design for these patients, since contemporary data suggest patients with this entity may be best served more intensive chemotherapy, however patients with known c-myc positive are NOT excluded from this study. C-myc testing prior to study enrollment is NOT required.
(3) Stage II bulky disease, stage III or IV.
(4) A tumor tissue specimen from the initial diagnostic biopsy has been located and ready to ship to the ECOG Pathology Coordinating Office within 30 days following registration.
Patients must have paraffin-embedded tumor specimen available for central pathology review and defined laboratory research studies.
(5) IPI of 2 or greater
(6) ECOG performance status 0-2
(7) Patients must have measurable disease (at least 1 lesion of >= 1.5 cm in one diameter) as detected by CT or the CT images of the PET/CT
(8) Previously untreated and not receiving any other agent that would be considered as a treatment for the lymphoma
(9) No known CNS lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells. These patients are usually treated with CNS directed therapy. Screening for CSF/CNS involvement is NOT required but can be performed per treating MD discretion.
(10) Adequate organ function
(11) Ejection fraction of >=45% by either MUGA or ECHO.
(12) Must be able/willing to receive anticoagulation therapy with aspirin 325 mg daily prophylaxis, low molecular weight heparin, or Warfarin.
(13) Must not be receiving erythroid stimulating agents.
(14) Must be willing to provide informed written consent and to return to enrolling institution for follow-up.
(15) Women must not be pregnant or breast-feeding.
(16) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 x 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
(17) Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.