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
- 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
- Determine the time to disease progression in patients responding to this regimen.
- Determine the percentage of donor chimerism achieved in patients treated with this
- 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
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.
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
Thomas C. Shea, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|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|