Refractory Acute Leukemia Clinical Trial
Official title:
Allo-allo Tandem Matched Stem Cell Transplantation (AATT) for the Treatment of Patients With Refractory Acute Leukemia; a Feasibility Phase I/II Study
Refractory acute leukemia (AL) occurs in a significant percentage of the AL patients and presents a therapeutic challenge. Allogeneic stem cell transplantation (allo-SCT) is the only curative option for these patients. Although many of the patients with refractory AL that undergo myeloablative SCT initially achieve complete remission, most relapse later on, and the long-term disease free survival is poor. In order to achieve better leukemic control, most transplant centers employ post transplant early withdrawal of the anti-GVHD immunosuppression; hence exposing the patients to high risk of GVHD associated morbidity and mortality. This study will try to address this common scenario, namely early and late relapse. The investigators will try to attain better leukemic control by re-inducing the patients, 6 weeks after the 1st transplant with further myeloablative treatment (busulfex and thiotepa) followed by allogeneic stem cell support (transplant II).
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
employed.
Treatment schedule:
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.
Conditioning protocol:
All patients will be prepared by the same sequential conditioning protocols:
Transplant I: Cy-TBI followed by Transplant II: Busulfan-thiotepa.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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