A Phase 2 interventional study of busulfan and cyclophosphamide in Chronic Myeloproliferative Disorders, Leukemia and Myelodysplastic/Myeloproliferative Diseases, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged Up to 65 Years. Per ClinicalTrials.gov, last updated 2010-04-02.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.
OBJECTIVES:
OUTLINE: Patients receive a preparative regimen consisting of oral busulfan every 6 hours on days -7 through -4 and cyclophosphamide on days -3 and -2. Patients then receive allogeneic bone marrow or peripheral blood stem cells on day 0. Patients registered on protocol FHCRC-1106.00 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem cells from an HLA-identical donor.
Patients receive cyclosporine/methotrexate or tacrolimus/methotrexate as prophylaxis for graft-versus-host disease (GVHD). Patients receiving marrow from unrelated donors are eligible for appropriate GVHD prophylaxis studies.
Patients are followed at 6 and 12 months after transplant.
PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study over approximately 3.5 years.
626 studies on the registry are indexed under Myeloproliferative Disorders; 109 are open to participants now.
This study's planned enrollment of 20 is below the median of 45 across 439 interventional studies indexed under Myeloproliferative Disorders.
Browse Myeloproliferative Disorders studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Idiopathic myelofibrosis (IMF) with at least 1 poor prognosis characteristic, including but not limited to:
No evidence of leukemic progression, e.g.:
No other causes for myelofibrosis, such as:
One of the following donor/patient pairings is required:
Donor status:
Genotypic or phenotypic HLA-matched relative
One antigen HLA-mismatched relative, HLA-matched unrelated donor, or one antigen HLA-mismatched unrelated donor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Fred Hutchinson Cancer Center