Study to Compare Busulfan-fludarabine With Thiotepa-fludarabine Regimen in Allogeneic Transplantation for Myelofibrosis
Status:
Completed
Trial end date:
2016-12-31
Target enrollment:
Participant gender:
Summary
This study will be performed as a prospective multicenter phase II trial for compare
busulfan-fludarabine reduced-intensity conditioning (RIC) with thiotepa-fludarabine RIC
regimen prior to allogeneic transplantation of hematopoietic cells for the treatment of
myelofibrosis.
The primary endpoint for this study is to compare Progression Free Survival of two different
RIC regimens for allogeneic stem cell transplantation in myelofibrosis.
Progression Free Survival is defined as the time from the date of randomization to the date
of the first documented disease progression or relapse (according to the International
Working Group Consensus Criteria) or death due to any cause. Patients who have neither
progressed nor died at the time of study completion or who are lost to follow-up are censored
at the data of the last follow up for progression of disease for this study.