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Protocol Summary


Protocol No.
PSCI-18-011
Prinicipal Investigator
Naik, Seema
Phase
Phase II
Age Group
Adult
Scope
Local
Title
Clofarabine followed by Fludarabine, Busulfan, Total-Body Irradiation and Hematopoietic Stem Cell Transplant with Post-Transplant Cyclophosphamide for Non-remission Acute Myeloid Leukemia
Objective
Primary Objective:
The primary objective is to determine the incidence of complete remission (CR) at day +30 post HSCT after Clofarabine followed by Hematopoietic Stem Cell Transplant (HSCT) using Fludarabine, Busulfan (FluBu), and total body irradiation (TBI) with Post-Transplant Cyclophosphamide (PTCy).
Secondary Objectives:
- To determine disease-free survival (DFS) and overall survival (OS) following HSCT using PTCy.
- To determine the rate of non-relapse related mortality (NRM) at day 100.
- To determine the incidence and severity of acute and chronic graft versus host disease (GVHD).
- To determine the rate of engraftment.
Applicable Disease Sites
Leukemia, not otherwise specified
Status
Open
Participating Institutions
Hershey Medical Center