Ignite Creation Date:
2025-12-18 @ 9:32 AM
Ignite Modification Date:
2025-12-18 @ 9:32 AM
Study NCT ID:
NCT00843947
Status:
None
Last Update Posted:
2017-06-27 00:00:00
First Post:
2009-02-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan
Sponsor:
None
Organization:
Study Overview
Official Title:
Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan
Status:
None
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: