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NCT00943319 · ClinicalTrials.gov registry record · Phase 1
Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
A Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00943319 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 50 participants.
The verdict
NCT00943319, a Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Campath
- PROCEDURE Stem Cell Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-03 |
| Est. Completion | 2018-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00943319
The ClinicalTrials.gov registry entry for NCT00943319 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT00943319 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00943319 about?
NCT00943319 is a clinical study titled "Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies". The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning re...
What is the current status of trial NCT00943319?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2012-03. Estimated completion is 2018-12.
What interventions are being tested in trial NCT00943319?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Campath (DRUG), Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT00943319?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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