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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 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00623935
The ClinicalTrials.gov registry entry for NCT00623935 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT00623935 reports 0 study locations.
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.
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