Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, and Mantle Cell Lymphoma With Allogeneic Donor Stem Cells
OBJECTIVES:
- Determine the feasibility of fludarabine and cyclophosphamide followed by allogeneic
peripheral blood stem cell transplantation, in terms of 6-month treatment-related
mortality, in patients with chronic lymphocytic leukemia, prolymphocytic leukemia,
low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.
- Determine the 6-month and 12-month probabilities of response in patients treated with
this regimen.
- Determine the time to disease progression in patients responding to this regimen.
- Determine the percentage of donor chimerism achieved in patients treated with this
regimen.
- Determine the risk of acute and chronic graft-versus-host disease in patients treated
with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival and disease-free survival of patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV
over 1 to 2 hours on days -5 to -3. Patients undergo allogeneic peripheral blood stem cell
transplantation on days 0-1. Patients then receive filgrastim (G-CSF) subcutaneously daily
beginning on day 5 and continuing until blood counts recover.
Patients with no signs of active graft-versus host disease and stable or progressive disease
receive donor lymphocytes IV over 2 hours beginning after day 120. Patients may receive a
total of 3 infusions at least 8 weeks apart if disease remains stable or progressive.
Patients are followed every 3 months for 2 years and then every 6 months for 5 years.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related mortality within the first 6 months post-transplant
6 months post chemo initiation
Yes
Thomas C. Shea, MD
Study Chair
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
CDR0000068185
NCT00006252
February 2001
October 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Elmhurst Hospital Center | Elmhurst, New York 11373 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Mount Sinai Medical Center | New York, New York 10029 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |
Beebe Medical Center | Lewes, Delaware 19958 |
St. Francis Hospital | Wilmington, Delaware 19805 |
Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |