NCT00843947

Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II trial designed to evaluate the efficacy and toxicity of RIST, conditioned with fludarabine and busulfan, using G-CSF mobilized PBSC from an HLA-matched sibling or an unrelated volunteer donor. The primary endpoint of this study is day 100 TRM (Treatment Related Mortality). Secondary endpoints include response, engraftment times, acute and chronic GVHD, chimerism, toxicities, progression-free survival and overall survival. Objectives * To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan intravenous (Busulfex™). * To evaluate progression-free survival and overall survival. * To determine donor chimerism. * To assess the risk of acute and chronic graft versus host disease (GVHD).

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
PROCEDURE	Reduced Intensity Stem Cell Transplantation	Reduced Intensity Stem Cell Transplantation

Timeline

• Start date: 2007-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2009-02-13
• Last updated: 2017-06-27

Locations

1 site across 1 country: United States