Hematologic Malignancies Clinical Trial
Official title:
Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan
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).
n/a
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