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NCT01168219 · ClinicalTrials.gov registry record · Phase 2
Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT01168219: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01168219 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 68 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01168219, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study Summary
This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in treating patients with high-risk myelodysplastic syndrome and older patients with acute myeloid leukemia. Giving low doses of chemotherapy, such as busulfan and fludarabine phosphate, before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-vs-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving anti-thymocyte globulin before transplant and giving azacitidine, tacrolimus, and methotrexate after the transplant may stop this from happening.
Interventions
- DRUG Busulfan
- DRUG Azacitidine
- BIOLOGICAL Anti-Thymocyte Globulin
- DRUG Fludarabine Phosphate
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2010-07-15 |
| Est. Completion | 2020-02-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01168219
The ClinicalTrials.gov registry entry for NCT01168219 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Busulfan is the first listed.
NCT01168219 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01168219 about?
NCT01168219 is a clinical study titled "Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia". This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in treating patients with high-risk myelodysplastic syndrome and older patients with acute myeloid leukemia. Giving low d...
What is the current status of trial NCT01168219?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2010-07-15. Estimated completion is 2020-02-01.
What interventions are being tested in trial NCT01168219?
The interventions under investigation include: Busulfan (DRUG), Azacitidine (DRUG), Anti-Thymocyte Globulin (BIOLOGICAL), Fludarabine Phosphate (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01168219?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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