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NCT01056614 · ClinicalTrials.gov registry record · Phase 2
Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01056614: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT01056614 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01056614, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase II trial is studying the side effects and how well giving fludarabine phosphate, busulfan, anti-thymocyte globulin followed by donor peripheral blood stem cell transplant, tacrolimus, and methotrexate works in treating patients with myeloid malignancies. Giving chemotherapy, such as fludarabine phosphate and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving anti-thymocyte globulin before transplant and tacrolimus and methotrexate after transplant may stop this from happening.
Primary Outcome
Maximum grade of acute GVHD and the number of therapies required to treat GVHD will be determined.
Interventions
- DRUG fludarabine phosphate
- DRUG tacrolimus
- DRUG methotrexate
- DRUG busulfan
- BIOLOGICAL anti-thymocyte globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2004-09 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01056614 record still lists
NCT01056614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT01056614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01056614 about?
NCT01056614 is a clinical study titled "Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies". This phase II trial is studying the side effects and how well giving fludarabine phosphate, busulfan, anti-thymocyte globulin followed by donor peripheral blood stem cell transplant, tacrolimus, and methotrexate works in treating patients with myeloid malignancies. Giving chemotherapy, such as fluda...
What is the current status of trial NCT01056614?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2004-09. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01056614?
The interventions under investigation include: fludarabine phosphate (DRUG), tacrolimus (DRUG), methotrexate (DRUG), busulfan (DRUG), anti-thymocyte globulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT01056614?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01056614's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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