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NCT00469144 · ClinicalTrials.gov registry record · Phase 3
IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
A Phase 3 study of Acute Myeloid Leukemia and Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
- 1
- Study location
NCT00469144: Completed Phase 3 study of Acute Myeloid Leukemia and Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT00469144 is a Phase 3 study of Acute Myeloid Leukemia and Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 233 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (103% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00469144, a Phase 3 study of Acute Myeloid Leukemia and Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if giving busulfan in a dose based on blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and causes fewer side effects for AML or myelodysplastic syndrome patients than the standard method of giving a fixed busulfan dose based on body size, along with a fixed dose of fludarabine. The safety of dosing based on blood levels will also be studied.
Primary Outcome
Time to failure (TTF) defined as either disease recurrence or death, from the time of bone marrow transplant (BMT) and reported as TRM at 100 days and 1 year. Treatment period defined as BMT Day -9 for patients treated on the PK-guided treatment arm, and day -7 for patients receiving the fixed-dose busulfan treatment through BMT Day +28. The post study surveillance period is defined as BMT Day +29 through BMT Day +100. Bone marrow aspirate with cytogenetics at approximately one (1) month and th
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Busulfan
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2005-06 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT00469144 record still lists
NCT00469144 is an interventional study that assigns participants to a tested intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (103% higher).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Fludarabine is the first listed.
NCT00469144 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00469144 about?
NCT00469144 is a clinical study titled "IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome". The goal of this clinical research study is to learn if giving busulfan in a dose based on blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and causes fewer side effects for AML or myelodysplastic syndrome patients than the standard method of giving a fixed busulf...
What is the current status of trial NCT00469144?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2005-06. Estimated completion is 2014-11.
What conditions does trial NCT00469144 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT00469144?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG).
Who is sponsoring clinical trial NCT00469144?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00469144 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00469144's enrollment target sits among peer trials
233 38th of 306 higher than 269 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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