Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Graft Versus Host Disease, Lymphoma
About this trial
This is an interventional treatment trial for Graft Versus Host Disease focused on measuring graft versus host disease, stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma
Eligibility Criteria
Documentation of Disease Histologically documented mantle cell lymphoma of any stage (needle or core biopsy is not acceptable as the sole means of diagnosis) with at least one of the following confirmatory tests indicative of diagnosis: Immunophenotype with expression of CD5 and CD19 and absence of CD23 Cytogenetic analysis with presence of t(11;14) Overexpression of cyclin D1 Rearrangement of BCL1 gene Rebiopsy of a node at relapse is recommended but not required. Bone marrow biopsy required for pretreatment evaluation. Bilateral biopsies are not required. Identification of HLA-Matched sibling donor - The sibling donor must meet eligibility criteria outlined in section 5.0 Prior Therapy Patients who have failed initial therapy are eligible (without any of the poor prognostic characteristics listed in the protocol). Failure to initial treatment is defined as one of the following: Failure to achieve clinical complete remission after treatment with an anthracycline-containing regimen Disease recurrence after initial treatment (with an anthracycline-containing regimen) Patients in first remission must have one of the following poor prognostic characteristics: International Prognostic Index (IPI) score > 1. IPI risk factors include the following: age > 60 (not eligible for this protocol); performance status > 1; LDH > normal; presence of > 1 extranodal sites; and stage III/IV disease Blastic variant of mantle cell lymphoma (regardless of IPI score) Complex karyotypes (i.e., cytogenetic abnormalities different from or in addition to t(11;14) (regardless of IPI score) Proliferative index > 10% (regardless of IPI score) Presence of p53 mutations Patients who have received more than two chemotherapy regimens are ineligible. Patients who have undergone a prior bone marrow transplant are not eligible. Age < 60 years No active CNS lymphoma DLCO ≥ 40% and no symptomatic pulmonary disease No HIV infection Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control. Initial required laboratory values bilirubin < 2 mg/dl AST ≤ 3 x upper limit of normal (ULN) ALT ≤ 3 x ULN serum creatinine < 2 mg/dl u-HCG or serum HCG negative (if patient of childbearing potential)
Sites / Locations
- Veterans Affairs Medical Center - Birmingham
- University of California San Diego Cancer Center
- Veterans Affairs Medical Center - San Francisco
- UCSF Cancer Center and Cancer Research Institute
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center
- Walter Reed Army Medical Center
- CCOP - Mount Sinai Medical Center
- University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Holden Comprehensive Cancer Center
- Veterans Affairs Medical Center - Togus
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Dana-Farber Cancer Institute
- University of Massachusetts Memorial Medical Center - University Campus
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center - Columbia
- Barnes-Jewish Hospital
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Presbyterian Hospital - Cornell Campus
- Mount Sinai Medical Center, NY
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Lineberger Comprehensive Cancer Center, UNC
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital - Ohio State University
- Rhode Island Hospital
- University of Tennessee Cancer Institute
- Veterans Affairs Medical Center - Memphis
- Green Mountain Oncology Group
- Vermont Cancer Center
- Veterans Affairs Medical Center - White River Junction
- Veterans Affairs Medical Center - Richmond
- MBCCOP - Massey Cancer Center
Arms of the Study
Arm 1
Experimental
chemotherapy + stem cell transplantation
Patients receive carmustine, etoposide, cytarabine and melphalan on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus on day -2 and then orally twice daily until day 120 and methotrexate on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim daily beginning on day 7 and continuing until blood counts recover. Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists. Patients are followed at 6 and 12 months post-transplantation and then annually for 4 years.