Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma
- Conditions
- LymphomaLeukemia
- Interventions
- Biological: PBSCBiological: Donor lymphocytes
- Registration Number
- NCT00006252
- Lead Sponsor
- Cancer and Leukemia Group B
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Allogeneic Stem Cell Tx G-CSF minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy Allogeneic Stem Cell Tx fludarabine phosphate minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy Allogeneic Stem Cell Tx PBSC minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy Allogeneic Stem Cell Tx Donor lymphocytes minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy Allogeneic Stem Cell Tx Cyclophosphamide minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy
- Primary Outcome Measures
Name Time Method Treatment-related mortality within the first 6 months post-transplant 6 months post chemo initiation
- Secondary Outcome Measures
Name Time Method Response 6 months & 12 months Percentage of patients achieving complete donor chimerism or mixed donor chimerism 90 days post transplant Survival 5 years post study entry Disease free and overall survival will be assessed
Trial Locations
- Locations (19)
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
🇺🇸Voorhees, New Jersey, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Union Hospital Cancer Center at Union Hospital
🇺🇸Elkton MD, Maryland, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
St. Francis Hospital
🇺🇸Wilmington, Delaware, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States