Status:
COMPLETED
Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility:
All Genders
Up to 65 years
Phase:
NA
Brief Summary
This trial is studying the side effects and how well giving cyclophosphamide and busulfan followed by donor stem cell transplant works in treating patients with myelofibrosis, acute myeloid leukemia, ...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the incidence of hepatotoxicity with a conditioning regimen of CY (cyclophosphamide)/tBU (busulfan) in patients receiving hematopoietic cell transplant (HCT). SECO...
Eligibility Criteria
Inclusion
- Idiopathic myelofibrosis (CIMF)
- Myelofibrosis developing with polycythemia vera or essential thrombocythemia
- Acute myeloid leukemia with or without antecedent hematologic disorder, at any disease stage (complete remission, minimal residual disease, or relapsed leukemia)
- Myelodysplastic syndrome of any World Health Organization (WHO) or French-American-British (FAB) category, at any disease stage
- Less than 61 years of age if transplanted from an unrelated donor, or less than 66 years of age if transplanted from a related donor
- Receiving unmanipulated peripheral blood stem cells from an human leukocyte antigen (HLA)-identical or 1-allele-mismatched related or unrelated donor, or receiving G-CSF-stimulated bone marrow if co-enrolled on Fred Hutchinson Cancer Research Center (FHCRC) protocol 2250
- With a Karnofsky Performance score of \> 70% at the time of pre-transplant evaluation
- Able to give informed consent (if \>= 18 years of age), or with a legal guardian capable of giving consent (if \< 18 years of age)
- DONOR: HLA-identical or 1-allele-mismatched related or unrelated donors (by high resolution typing)
- DONOR: Undergoing peripheral blood stem cell harvest or G-CSF-stimulated bone marrow harvest (bone marrow permitted only as part of FHCRC protocol 2250)
- DONOR: In good general health, with a Karnofsky performance score of \> 80%
- DONOR: Able to give informed consent (if \>= 18 years of age), or with a legal guardian able to give informed consent (if \< 18 years of age and donating for a related transplant)
Exclusion
- Without an HLA-identical or 1-allele-mismatched related or unrelated donor
- With human immunodeficiency virus (HIV) positivity or active infectious hepatitis
- Receiving a medication known to strongly inhibit enzymes in the CYP450 pathway, and which, in the judgment of the consenting provider, cannot be safely discontinued for the duration of conditioning
- Whose life expectancy is severely limited by diseases other than the hematologic disorder for which they are undergoing HCT (HCT-comorbidity index \[CI\] \> 3)
- Women who are pregnant or lactating
- With known hypersensitivity to BU or CY
- With hepatic dysfunction as evidenced by total bilirubin or AST \> 2x the upper limit of normal, or evidence of synthetic dysfunction or cirrhosis
- With impaired renal function, as evidenced by creatinine clearance \< 50% of expected, creatinine \> 2x the upper limit of normal, or dialysis dependence
- With impaired pulmonary function, as evidenced by pO2 \< 70 mm Hg and diffusing capacity of carbon monoxide (DLCO) \< 70% predicted or by pO2 \< 80 mm Hg and DLCO \< 60%, or receiving continuous supplementary oxygen
- With impaired cardiac function, as evidenced by ejection fraction \< 35% or active coronary artery disease
- Unable to give informed consent
- DONOR: Deemed unable to undergo stem cell collection, for any reason
- DONOR: HIV-positive, or hepatitis B or C antigen-positive
- DONOR: Women with a positive pregnancy test
- DONOR: Unable to give informed consent (if \>= 18 years of age), or without a legal guardian able to give informed consent (if \<18 years of age)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00445744
Start Date
December 1 2006
End Date
June 1 2013
Last Update
January 2 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109