Allo-allo Tandem Matched Stem Cell Transplantation (AATT) for the Treatment of Patients With Refractory Acute Leukemia; a Feasibility Phase I/II Study
The effects of feasibility oExperimental design and methods f allo-allo tandem matched stem
cell transplantation (AATT) in patients with refractory leukemia will be evaluated in a
clinical setting. The current study is limited only for patients with refractory disease
that received and failed up to 2 lines of salvage therapy, in good performance status and
younger than 50 years old. Only patients that will achieve complete remission after
transplant I, will have no major organ dysfunction and with acceptable performance status,
will be treated with transplant II. Close monitoring with strict stopping rules including in
case of excess transplant related morality, acute or chronic GVHD or graft failure will be
15 patients (divided into 2 cohorts, see below) with matched family member or unrelated
donor will be included in single arm open phase I/II trial.
All patients will be prepared by the same sequential conditioning protocols:
Transplant I: Cy-TBI followed by Transplant II: Busulfan-thiotepa.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Transplant-related mortality (TRM) of SCT II.
Israel: Israeli Health Ministry Pharmaceutical Administration