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NCT00572897 · ClinicalTrials.gov registry record · Phase 2
Study of Fludarabine Based Conditioning for Allogeneic Stem Cell Transplantation for Myelofibrosis
A Phase 2 study, sponsored by John Mascarenhas.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT00572897: Completed Phase 2 study, sponsored by John Mascarenhas.
NCT00572897 is a Phase 2 study that has completed, run by John Mascarenhas. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00572897, a Phase 2 study, has completed, sponsored by John Mascarenhas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
Stem cell transplantation is used to treat may types of diseases. There a 2 types of transplants, conventional (very intense) and reduced intensity-non-myeloablative, also called mini-transplants. This study proposes to use a conditioning regimen for allogeneic transplantation along with a reduced intensity transplant. Conditioning regiment is the name for the combination of chemotherapy drugs that is given to patients before receiving a transplantation of donor stem cells. It is hoped that the regimen designed for this study proves to be less toxic and has an equal or better anticancer effect than the regimens that are normally used. The regimen being used is a combination of two chemotherapy drugs, fludarabine and melphalan. This regimen has been studied in recipients of matched sibling transplants and in recipients of alternative donor stem cells in other hematologic malignancies. Those subjects, who receive stem cells from an unrelated donor, will also receive and additional drug called ATG or anti thymocyte globulin. ATG suppresses the immune system, thus reducing the chances for the recipient rejecting the transplant (graft). The purpose of this study is to observe if reduced intensity transplants can be used to allow engraftment or "take" of the donor's bone marrow. Studies conducted in the past show this type of transplant is much less toxic than traditional bone marrow transplants. Reduced intensity transplants may be better tolerated by patients who may experience serious side effects from standard (very intense) stem cell transplant. The study has been recently amended to follow all subjects for survival.
Primary Outcome
Number of participants alive at 2 years who are progression-free
Interventions
- DRUG Fludarabine, Melphalan +/- ATG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2007-08 |
| Est. Completion | 2015-06-15 |
| Phase | Phase 2 |
What the finished NCT00572897 record still lists
NCT00572897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Fludarabine, Melphalan +/- ATG is the first listed.
NCT00572897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00572897 about?
NCT00572897 is a clinical study titled "Study of Fludarabine Based Conditioning for Allogeneic Stem Cell Transplantation for Myelofibrosis". Stem cell transplantation is used to treat may types of diseases. There a 2 types of transplants, conventional (very intense) and reduced intensity-non-myeloablative, also called mini-transplants. This study proposes to use a conditioning regimen for allogeneic transplantation along with a reduced ...
What is the current status of trial NCT00572897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2007-08. Estimated completion is 2015-06-15.
What interventions are being tested in trial NCT00572897?
The interventions under investigation include: Fludarabine, Melphalan +/- ATG (DRUG).
Who is sponsoring clinical trial NCT00572897?
This trial is sponsored by John Mascarenhas, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00572897's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 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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