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

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.

Timeline

Start

2012-03

Primary completion

2017-12

Completion

2018-12

Publications

• O'Donnell PH, Artz AS, Undevia SD, Pai RK, Del Cerro P, Horowitz S, Godley LA, Hart J, Innocenti F, Larson RA, Odenike OM, Stock W, Van Besien K. Phase I study of dose-escalated busulfan with fludarabine and alemtuzumab as conditioning for allogeneic hematopoietic stem cell transplant: reduced clearance at high doses and occurrence of late sinusoidal obstruction syndrome/veno-occlusive disease. Leuk Lymphoma. 2010 Dec;51(12):2240-9. doi: 10.3109/10428194.2010.520773. Epub 2010 Oct 4.

Drugs

Indications