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NCT01457885 · ClinicalTrials.gov registry record · Phase 2
Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT01457885: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT01457885 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01457885, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
Although transplant results for AML in complete remission (CR) at the time of transplant have improved, transplant results for non-remission AML have been quite poor. Most multi-center studies have focused on standard risk AML patients and not many studies have been done in this population of patients with non-remission AML. There are a large number of older patients with non-remission AML because the complete remission rate with induction chemotherapy decreases with age. Such older patients do not tolerate conventional full intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for non-remission AML is a great unmet need for current transplant practice. From the investigators earlier study, it is suggested that replacing Fludarabine of standard FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in the transplant conditioning regimen may potentiate the anti-tumor activity of the conditioning regimen without adding significant toxicity, a goal of new conditioning regimen development. The investigators expect to enroll a total of 75 patients from about fifteen sites. The investigators main objective is to confirm both the safety and efficacy as measured by one-year overall survival, of the CloBu4 combination as full intensity conditioning for non-remission acute myelogenous leukemia.
Primary Outcome
Percentage of patients passed without relapse/recurrence at 1 year.
Interventions
- DRUG Clofarabine/Busulfan x 4
- PROCEDURE Peripheral blood stem cell transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-06-14 |
| Phase | Phase 2 |
What the finished NCT01457885 record still lists
NCT01457885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Clofarabine/Busulfan x 4 is the first listed.
NCT01457885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01457885 about?
NCT01457885 is a clinical study titled "Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen". Although transplant results for AML in complete remission (CR) at the time of transplant have improved, transplant results for non-remission AML have been quite poor. Most multi-center studies have focused on standard risk AML patients and not many studies have been done in this population of patien...
What is the current status of trial NCT01457885?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2011-11. Estimated completion is 2016-06-14.
What interventions are being tested in trial NCT01457885?
The interventions under investigation include: Clofarabine/Busulfan x 4 (DRUG), Peripheral blood stem cell transplant (PROCEDURE).
Who is sponsoring clinical trial NCT01457885?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01457885's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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