Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
In the United States, thiotepa has been utilized in reduced intensity conditioning regimens
for alternative donor courses (double umbilical cord blood transplant (dUCBT) and
haplo-identical transplants).
The hypothesis is that thiotepa at a dose of 10mg/kg, in combination with melphalan
(100mg/m2) and fludarabine (160mg/m2) as a reduced intensity conditioning regimen for
alternative donor transplant is safe and effective in patients with hematologic malignancies.
Given that this regimen has been investigated extensively, and the current study proposes to
confirm those previous observations with a small modification (melphalan dose reduction due
to previous mucositis rates with higher doses), this will be a phase II study designed to
measure disease-free-survival.