Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma
NCT ID: NCT00006252
Last Updated: 2016-07-18
Study Results
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Basic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2001-02-28
2011-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Allogeneic Stem Cell Tx
minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy
fludarabine phosphate
30 mg/sq m/day IV infusion for 5 days (Days -7 thru -3)
Cyclophosphamide
1 g/sq m/day IV infusion x 3 days (Days -5 thru -3)
PBSC
2-8,000,000/kg CD34+ cells via infusion on Day 0
G-CSF
5 ug/kg/day subQ injection until ANC \> 1000/uL for 3 days beginning Day 5
Donor lymphocytes
10,000,000 CD3+ cells/kg via infusion
Interventions
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fludarabine phosphate
30 mg/sq m/day IV infusion for 5 days (Days -7 thru -3)
Cyclophosphamide
1 g/sq m/day IV infusion x 3 days (Days -5 thru -3)
PBSC
2-8,000,000/kg CD34+ cells via infusion on Day 0
G-CSF
5 ug/kg/day subQ injection until ANC \> 1000/uL for 3 days beginning Day 5
Donor lymphocytes
10,000,000 CD3+ cells/kg via infusion
Eligibility Criteria
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Inclusion Criteria
* At least 1 of the following:
* Immunophenotypic expression of CD5 and CD19 and absence of CD23
* Cytogenetic analysis with presence of t(11;14)
* Overexpression of cyclin D1
* Rearrangement of BCL1 gene
* Responsive or stable disease to most recent prior therapy
* Prior therapy for PLL not required
* Must have HLA identical sibling (6/6) donor by serologic typing (A, B, DR)
* No syngeneic donors
* No age restriction NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* Under 70
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 500/mm\^3\*
* Platelet count at least 50,000/mm\^3\* NOTE: \*Unless attributable to disease
Hepatic:
* Bilirubin no greater than 3 times upper limit of normal (ULN)\*
* AST no greater than 3 times ULN\* NOTE: \*Unless attributable to disease
Renal:
* Creatinine clearance at least 40 mL/min, unless attributable to disease
Cardiovascular:
* LVEF at least 30% by MUGA
Pulmonary:
* DLCO greater than 40%
* No symptomatic pulmonary disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No uncontrolled diabetes mellitus
* No active serious infection
* No known hypersensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior autologous transplantation
Chemotherapy:
* At least 4 weeks since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* At least 4 weeks since prior surgery
69 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cancer and Leukemia Group B
NETWORK
Responsible Party
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Principal Investigators
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Thomas Shea, MD
Role: STUDY_CHAIR
UNC Lineberger Comprehensive Cancer Center
Locations
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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
Roswell Park Cancer Institute
Buffalo, New York, United States
Elmhurst Hospital Center
Elmhurst, 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
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 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
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Shea T, Johnson J, Westervelt P, Farag S, McCarty J, Bashey A, Isola L, Baxter-Lowe LA, Kelly M, Owzar K, Linker C; Cancer and Leukemia Group B. Reduced-intensity allogeneic transplantation provides high event-free and overall survival in patients with advanced indolent B cell malignancies: CALGB 109901. Biol Blood Marrow Transplant. 2011 Sep;17(9):1395-403. doi: 10.1016/j.bbmt.2011.01.016. Epub 2011 Feb 3.
Other Identifiers
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CALGB-109901
Identifier Type: -
Identifier Source: secondary_id
CDR0000068185
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-109901
Identifier Type: -
Identifier Source: org_study_id
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