Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
|ClinicalTrials.gov Identifier: NCT00943319|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2009
Last Update Posted : February 1, 2018
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 :||51 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|
|Estimated Study Completion Date :||December 2018|
Experimental: Busulfan and fludarabine
Intravenous busulfan (Busulfan®) in combination with fludarabine
Daily intravenous dosing to target AVCDrug: Fludarabine
Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.Drug: Campath
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).
- Toxicity [ Time Frame: 5 years ]
- Evaluate disease free and overall survival [ Time Frame: 5 years ]
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|