RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
30 mg/sq m/day IV infusion for 5 days (Days -7 thru -3)
1 g/sq m/day IV infusion x 3 days (Days -5 thru -3)
2-8,000,000/kg CD34+ cells via infusion on Day 0
5 ug/kg/day subQ injection until ANC \> 1000/uL for 3 days beginning Day 5
10,000,000 CD3+ cells/kg via infusion
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
St. Francis Hospital
Wilmington, Delaware, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees Township, New Jersey, United States
...and 9 more locations
Treatment-related mortality within the first 6 months post-transplant
Time frame: 6 months post chemo initiation
Response
Time frame: 6 months & 12 months
Percentage of patients achieving complete donor chimerism or mixed donor chimerism
Time frame: 90 days post transplant
Survival
Disease free and overall survival will be assessed
Time frame: 5 years post study entry
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