Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
This study is currently recruiting participants.
Verified July 2012 by University of Chicago
University of Chicago
Information provided by (Responsible Party):
Andrew Artz, MD, University of Chicago
First received: July 20, 2009
Last updated: July 22, 2012
Last verified: July 2012
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.
Procedure: Stem Cell Transplant
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluate disease free and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943319
|Contact: Andrew Artz, MDfirstname.lastname@example.org|
|United States, Illinois|
|The University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Andrew Artz, M.D. 773-834-8980|
|Contact: Paula Del Cerro, RN 773-702-2070 email@example.com|
|Principal Investigator: Koen van Besien, M.D.|
Sponsors and Collaborators
University of Chicago
|Principal Investigator:||Andrew Artz, MD||University of Chicago|