Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT00943319|
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
The purpose of this study is:
- 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.
- To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
- To evaluate potential pharmacogenomic determinants of toxicity of this regimen.
- To evaluate potential pharmacogenomic determinants of efficacy of this regimen.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Myeloma||Drug: Busulfan Drug: Fludarabine Drug: Campath Procedure: Stem Cell Transplant||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2012|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2018|
Experimental: Busulfan and fludarabine
Intravenous busulfan (Busulfan®) in combination with fludarabine
Daily intravenous dosing to target AVC
Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.
All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).
Procedure: Stem Cell Transplant
Infusion of bone marrow and donors(related/ unrelated).
- Maximum Tolerated Dose [ Time Frame: 5 years ]Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.
- Overall Survival [ Time Frame: 5 years ]Overall Survival measured as median survival in days
- Disease Free Survival [ Time Frame: 5 years ]Disease Free Survival measured by median survival time in days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943319
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Andrew Artz, MD||University of Chicago|