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NCT00568633 · ClinicalTrials.gov registry record · Phase 3
Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML
A Phase 3 study, sponsored by Stanford University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT00568633: Clinical Trial Phase 3 study, sponsored by Stanford University.
NCT00568633 is a Phase 3 study that was terminated before completion, run by Stanford University. The registered enrollment target is 58 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00568633, a Phase 3 study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study Summary
Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 years of age have a high risk of complications and therefore generally are excluded from this treatment option. Recently our group developed a transplantation strategy for older cancer patients that protects against transplant-associated complications, yet does not interfere with the ability of the transplanted donor cells to destroy cancer cells. With this new method, we can now safely evaluate transplantation as a curative therapy for AML patients over the age of 50. We have assembled clinical and scientific researchers throughout the state of California to study and compare bone marrow transplantation using our new approach with the best standard of care chemotherapy in AML patients over the age of 50. The results of this study have the potential to establish a new treatment standard that will improve survival of older AML patients.
Primary Outcome
Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion).
Interventions
- DRUG Anti-thymocyte globulin (ATG)
- DRUG Mycophenolate mofetil (MMF)
- PROCEDURE Allogeneic HSCT
- RADIATION Total lymphoid irradiation (TLI)
- DRUG Cyclosporine (CSP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2007-08 |
| Est. Completion | 2015-12-31 |
| Phase | Phase 3 |
Why NCT00568633 stopped before completion
NCT00568633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Anti-thymocyte globulin (ATG) is the first listed.
NCT00568633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00568633 about?
NCT00568633 is a clinical study titled "Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML". Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 year...
What is the current status of trial NCT00568633?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2007-08. Estimated completion is 2015-12-31.
What interventions are being tested in trial NCT00568633?
The interventions under investigation include: Anti-thymocyte globulin (ATG) (DRUG), Mycophenolate mofetil (MMF) (DRUG), Allogeneic HSCT (PROCEDURE), Total lymphoid irradiation (TLI) (RADIATION), Cyclosporine (CSP) (DRUG).
Who is sponsoring clinical trial NCT00568633?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00568633's enrollment target sits among peer trials
58 1825th of 2000 higher than 174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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