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NCT00843947 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan
A Phase 2 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00843947 is a Phase 2 study that has completed, run by University of California, Davis. The registered enrollment target is 8 participants.
The verdict
NCT00843947, a Phase 2 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study 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).
Interventions
- PROCEDURE Reduced Intensity Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-06 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00843947
The ClinicalTrials.gov registry entry for NCT00843947 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Reduced Intensity Stem Cell Transplantation is the first listed.
NCT00843947 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00843947 about?
NCT00843947 is a clinical study titled "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). Seconda...
What is the current status of trial NCT00843947?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2007-06. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00843947?
The interventions under investigation include: Reduced Intensity Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00843947?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
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