Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma
OBJECTIVES:
- Determine the long term disease-free survival of patients with mantle cell lymphoma
treated with etoposide, carmustine, melphalan, and cytarabine followed by allogeneic
peripheral blood stem cell transplantation.
- Determine the incidence of molecular remissions in these patients treated with this
regimen.
- Correlate the persistence of minimal residual disease with clinical outcome in these
patients treated with this regimen.
- Determine the effect of donor lymphocytes in patients with progressive disease after
treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive carmustine IV over 2 hours on day -6; etoposide IV over 3 hours and
cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses; and
melphalan IV over 20-30 minutes on day -1. Patients undergo allogeneic peripheral blood stem
cell (PBSC) transplantation on day 0. Patients also receive tacrolimus IV continuously over
24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV
over 30 minutes on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis.
Patients receive sargramostim (GM-CSF) IV or subcutaneously 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 posttransplantation and then annually for 4 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3.5 years.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
2 years
No
Koen Van Besien, MD
Study Chair
University of Chicago
United States: Federal Government
CDR0000068324
NCT00006747
November 2000
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
University of Illinois at Chicago | Chicago, Illinois 60612 |