Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support

Summary

Objectives: 1. To determine the relative toxicities, engraftment potential, kinetics of engraftment, degree of chimerism and disease control achieved with the combination of fludarabine and busulfan at different dose levels and different dose schedules in patients undergoing allogeneic stem cell transplant (SCT). 2. Determine pharmacokinetics, and toxicity of intravenous busulfan given at equal total dose levels given four times daily, or once daily. 3. In vivo determination of fludarabine inhibitory effects on DNA repair.

Timeline

Start

2003-11

Primary completion

2011-08

Completion

2011-08

Drugs

Indications