Spots Global Cancer Trial Database for Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
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Trial Identification
Brief Title: Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
Official Title: A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
Study ID: NCT00943319
Study Description
Brief Summary: The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Chicago, Chicago, Illinois, United States
Contact Details
Name: Andrew Artz, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
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