NCT00943319

Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Lymphoma
• Myeloma

Interventions

Type	Name	Description
DRUG	Busulfan	Daily intravenous dosing to target AVC
DRUG	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).

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2009-07-22
• Last updated: 2019-02-04
• Results posted: 2019-02-04

Locations

1 site across 1 country: United States