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NCT00502905 · ClinicalTrials.gov registry record · Phase 2
Busulfan and Fludarabine in Patients With AML and MDS
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT00502905: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00502905 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00502905, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
Primary Objectives: 1. To administer multiple doses of an intravenous formulation of busulfan (Bu) at a dose adjusted to yield a blood drug level with a median daily area under the plasma concentration curve (AUC) of approximately 6,500 µMol-min. This dose will be given intravenously over three hours once daily for four (4) days, in combination with Fludarabine at a dose of 40 mg/m2 as preparation for bone marrow or peripheral stern cell transplantation in patients with acute myeloid leukemia or myelodysplastic syndromes. 2. To determine the outcome of Acute Myeloid Leukemia (AML)/myelodysplastic syndromes (MDS) patients undergoing treatment with this regimen. Data regarding engraftment, toxicity, relapse rate, long-term (disease-free) outcome, and overall survival will be collected. 3. To determine the safety profile of this regimen when utilized as preparation for allogeneic transplantation. 4. To describe the plasma pharmacokinetics of busulfan when administered intravenously in this regimen.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2003-10 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00502905
The ClinicalTrials.gov registry entry for NCT00502905 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fludarabine is the first listed.
NCT00502905 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00502905 about?
NCT00502905 is a clinical study titled "Busulfan and Fludarabine in Patients With AML and MDS". Primary Objectives: 1. To administer multiple doses of an intravenous formulation of busulfan (Bu) at a dose adjusted to yield a blood drug level with a median daily area under the plasma concentration curve (AUC) of approximately 6,500 µMol-min. This dose will be given intravenously over three hou...
What is the current status of trial NCT00502905?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2003-10. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00502905?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG).
Who is sponsoring clinical trial NCT00502905?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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