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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00568633
The ClinicalTrials.gov registry entry for NCT00568633 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Anti-thymocyte globulin (ATG) is the first listed.
NCT00568633 reports 0 study locations.
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.
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