Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan
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|ClinicalTrials.gov Identifier: NCT00843947|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : June 27, 2017
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.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Procedure: Reduced Intensity Stem Cell Transplantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan|
|Actual Study Start Date :||June 2007|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Procedure: Reduced Intensity Stem Cell Transplantation
- To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan intravenous (Busulfex™) [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843947
|United States, California|
|University of CA, Davis Cancer Center|
|Sacramento, California, United States, 95817|