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NCT00469014 · ClinicalTrials.gov registry record · Phase 2
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT00469014: Completed Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.
NCT00469014 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 72 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00469014, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combination. Researchers also want to find out if combining busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine will improve the treatment, compared with the previous standard method using busulfan and fludarabine alone.
Primary Outcome
Number of participants with treatment related mortality (death) within the first 30 days following transplantation.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Clofarabine
- OTHER Stem Cell Infusion
- DRUG Thymoglobulin (ATG)
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2006-09 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT00469014 record still lists
NCT00469014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (38% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT00469014 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00469014 about?
NCT00469014 is a clinical study titled "Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia". The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combi...
What is the current status of trial NCT00469014?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2006-09. Estimated completion is 2013-03.
What conditions does trial NCT00469014 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT00469014?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Clofarabine (DRUG), Stem Cell Infusion (OTHER), Thymoglobulin (ATG) (DRUG).
Who is sponsoring clinical trial NCT00469014?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00469014 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 NCT00469014's enrollment target sits among peer trials
72 107th of 306 higher than 198 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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