Busulfan and Fludarabine Before Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
NCT ID: NCT00301912
Last Updated: 2012-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2002-01-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving busulfan together with fludarabine before donor stem cell transplant works in treating patients with hematologic cancer.
Detailed Description
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Primary
* Determine the safety, in terms of treatment-related mortality at 100 days post-transplantation, of a myeloablative preparative regimen comprising busulfan and fludarabine and graft-vs-host disease (GVHD) prophylaxis comprising tacrolimus and methotrexate in patients with hematopoietic disorders undergoing matched unrelated donor stem cell transplantation.
* Determine the efficacy, in terms of overall survival at 1-year post-transplantation, in patients treated with this regimen.
Secondary
* Determine organ toxicity in patients treated with this regimen.
* Determine neutrophil and platelet recovery in patients treated with this regimen.
* Determine the incidence and severity of acute and chronic GVHD in patients treated with this regimen.
OUTLINE:
* Myeloablative preparative regimen: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and fludarabine IV over 30 minutes on days -7 to -3.
* Allogeneic stem cell transplantation: Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover.
* Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously beginning on day -2 and continuing until discharged from the hospital (may convert to oral dosing administered twice daily when tolerated) and methotrexate IV over 15-30 minutes on days 1, 3, 6, and 11.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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filgrastim
busulfan
fludarabine phosphate
methotrexate
tacrolimus
allogeneic bone marrow transplantation
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* In second or greater remission
* Relapsed disease in a patient not eligible for autologous stem cell transplantation
* Multiple myeloma, meeting 1 of the following criteria:
* Stage II or III disease in first or greater relapse
* Refractory disease
* Newly diagnosed disease with chromosome 13 abnormalities
* Advanced myeloproliferative disease, meeting 1 of the following criteria:
* Myelofibrosis requiring \> 2 units of packed red blood cells each month
* Essential thrombocythemia or polycythemia rubra vera that has progressed to AML
* Failed prior AML therapy
* No active, uncontrolled CNS leukemia
* Not eligible for autologous or mini-allogeneic transplantation
* No fully matched or single-antigen mismatched sibling donor available
* HLA-matched unrelated donor available
* HLA typed at HLA-A, -B, -C, -DRB1 and/or -DQB1 by high-resolution techniques
* For patients without HLA identical donors, mismatches at DQ (i.e., 8/8 match) and 1 additional mismatch at the allele level at HLA-A, -B, -C, or -DRB1 (i.e., 7/8 molecular match) allowed
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Creatinine \< 2.0 mg/dL
* Pulmonary diffusing capacity \> 40% of predicted
* Cardiac ejection fraction \> 40% by MUGA or echocardiography
* No active liver disease
* Bilirubin ≤ 2.0 mg/dL
* Alkaline phosphatase \< 3 times upper limit of normal (ULN)
* AST \< 3 times ULN
* Hepatitis C or active hepatitis B (HBV) allowed provided a liver biopsy is performed and ≤ grade 2 inflammation is present
* Patients with active HBV viral replication must receive antiviral therapy
* HIV negative
* No ongoing active infection
* Not pregnant or nursing
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 3 weeks since prior chemotherapy except for hydroxyurea or imatinib mesylate
* More than 3 months since prior interferon
16 Years
60 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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UCSF Helen Diller Family Comprehensive Cancer Center
Principal Investigators
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Thomas G. Martin, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Countries
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Other Identifiers
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UCSF-02257
Identifier Type: -
Identifier Source: secondary_id
UCSF-2214
Identifier Type: -
Identifier Source: secondary_id
UCSF-H24045-22163-04
Identifier Type: -
Identifier Source: secondary_id
CDR0000463168
Identifier Type: -
Identifier Source: org_study_id