Study of Fludarabine Based Conditioning for Allogeneic Stem Cell Transplantation for Myelofibrosis
Status:
Completed
Trial end date:
2015-06-15
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
John Mascarenhas
Collaborators:
Myeloproliferative Disorders-Research Consortium National Cancer Institute (NCI) National Institutes of Health (NIH)