Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma
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|ClinicalTrials.gov Identifier: NCT00006252|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: fludarabine phosphate Drug: Cyclophosphamide Biological: PBSC Drug: G-CSF Biological: Donor lymphocytes||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||October 2011|
Experimental: Allogeneic Stem Cell Tx
minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy
Drug: fludarabine phosphate
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
Biological: Donor lymphocytes
10,000,000 CD3+ cells/kg via infusion
- 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 [ Time Frame: 5 years post study entry ]Disease free and overall survival will be assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006252
|United States, California|
|Rebecca and John Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0658|
|Veterans Affairs Medical Center - San Diego|
|San Diego, California, United States, 92161|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Delaware|
|Beebe Medical Center|
|Lewes, Delaware, United States, 19958|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|St. Francis Hospital|
|Wilmington, Delaware, United States, 19805|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|Union Hospital Cancer Center at Union Hospital|
|Elkton MD, Maryland, United States, 21921|
|United States, Massachusetts|
|UMASS Memorial Cancer Center - University Campus|
|Worcester, Massachusetts, United States, 01655|
|United States, New Jersey|
|Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Elmhurst Hospital Center|
|Elmhurst, New York, United States, 11373|
|Queens Cancer Center of Queens Hospital|
|Jamaica, New York, United States, 11432|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|United States, Pennsylvania|
|Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital|
|Pittsburgh, Pennsylvania, United States, 15224-1791|
|United States, Virginia|
|Massey Cancer Center at Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||Thomas Shea, MD||UNC Lineberger Comprehensive Cancer Center|