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NCT00623935 · ClinicalTrials.gov registry record · Phase 2
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT00623935: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00623935 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00623935, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates \< 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals \> 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.
Primary Outcome
The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals \> 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- RADIATION Total Body Irradiation
- PROCEDURE Stem Cell Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2007-03 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
What the finished NCT00623935 record still lists
NCT00623935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT00623935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00623935 about?
NCT00623935 is a clinical study titled "Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia". The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates \< 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by ...
What is the current status of trial NCT00623935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2007-03. Estimated completion is 2015-11.
What interventions are being tested in trial NCT00623935?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Total Body Irradiation (RADIATION), Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT00623935?
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 NCT00623935's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 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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