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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 is a Phase 2 study that has completed, run by John Mascarenhas. The registered enrollment target is 66 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00572897
The ClinicalTrials.gov registry entry for NCT00572897 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John Mascarenhas, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fludarabine, Melphalan +/- ATG is the first listed.
NCT00572897 reports 0 study locations.
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.
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