Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
NCT ID: NCT00049634
Last Updated: 2010-09-16
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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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2002-01-31
Brief Summary
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PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or myeloproliferative disorder.
Detailed Description
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* Determine the incidence of grades II, III, and IV graft-vs-host disease (GVHD) in patients with myelodysplastic syndromes (MDS), acute myeloid leukemia transformed from MDS, or myeloproliferative disorders treated with immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cell transplantation.
* Determine the incidence of graft failure, relapse, and transplant-related mortality by day 100 in patients treated with this regimen.
* Determine the incidence of chronic GVHD, in terms of number and duration of immunosuppressant therapies, in patients treated with this regimen.
* Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral blood stem cells.
OUTLINE: Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cells are infused on day 0.
Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours (orally twice daily when tolerated) on days -1 to 80 and then gradually tapered over 5 months beginning on day 81.
Patients are followed regularly through day 100 and then at 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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busulfan
cyclophosphamide
cyclosporine
methotrexate
in vitro-treated peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of 1 of the following:
* Myelodysplastic syndromes (MDS) that has advanced beyond refractory anemia (RA)
* RA with excess blasts (RAEB) (greater than 5% blasts)
* RAEB in transformation (greater than 20% but less than 30% blasts)
* Acute myeloid leukemia (greater than 30% blasts) that evolved from MDS
* Myeloproliferative disorder, including chronic myelomonocytic leukemia, agnogenic myeloid metaplasia, polycythemia vera, or essential thrombosis
* No chronic myelogenous leukemia with or without excess (greater than 5%) blasts
* Must have an HLA-identical, related donor
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Performance status
* Not specified
Life expectancy
* At least 6 months
Hematopoietic
* Not specified
Hepatic
* Bilirubin less than 2 times upper limit of normal (ULN)\*
* SGOT/SGPT less than 2 times ULN\* NOTE: \* Unless due to malignancy
Renal
* Creatinine no greater than 2.0 mg/dL OR
* Glomerular filtration rate at least 60 mL/min
Cardiovascular
* Cardiac ejection fraction at least 45%
Pulmonary
* DLCO at least 60% of predicted
Other
* HIV negative
* Human antimouse antibody negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other medical condition that would preclude study participation
* No hypersensitivity to cyclosporine
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior marrow transplantation
* No concurrent growth factors for 21 days after study transplantation
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Fred Hutchinson Cancer Research Center
Principal Investigators
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Ann E. Woolfrey, MD
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1628.00
Identifier Type: -
Identifier Source: secondary_id
NCI-H02-0099
Identifier Type: -
Identifier Source: secondary_id
CDR0000258137
Identifier Type: REGISTRY
Identifier Source: secondary_id
1628.00
Identifier Type: -
Identifier Source: org_study_id