A Pilot Study of Sorafenib (Soranex)® (FLT3 Inhibitor) Administeration as Maintenance Therapy Following Allogeneic Transplant for AML Patients with FLT3/ITD mutation

Improved relapse-free survival (RFS) for patients with FLT3/ITD AML with Maintenance therapy by a potent FLT 3inhibitor after allogeneic transplant

A concealed, randomized phase 3, triple blinded, controlled clinical trial with a parallel group design of 52 patients

Patients who have inclusion criteria that have admitted in HSCT wards of Shariati hospital will received oral Sorafenib (Soranex)® (200 mg 2 times per day) or placebo from engraftment for a 3 months period, without relapse or intolerance adverse effect.

Subjects with AML with the FLT3-ITD mutation who have undergone allogeneic HSCT peripheral blood able to swallow whole pills evidence of relapsed/recurrent/residual disease as assessed by bone marrow aspirate and biopsy performed between days 30-60 any other hemorrhage/bleeding or dermal complication related to intervention CTCAE v. 4.0 > = grade 3 within 4 weeks of starting study drug

Intervention group: Subjects will be taken Sorafenib (Soranex)® 400 mg per day orally beginning after the time of engraftment for a 3 months period. Sorafenib (Soranex)® tablets (200 mg) provided by Noavaran Droui Kimia Co. Control group: patients scheduled to receive allogenic HSCT consecutively screened for inclusion in the study and will received placebo BID orally beginning after the time of engraftment for a 3 months period.

Disease-free survival (DFS)

This is a randomized controlled clinical trial with parallel design. participants randomly allocated to one of two groups according to balanced block randomization method. Group A is considered as the (intervention) that will recive Sorafenib (Soranex) ® (FLT3 Inhibitor) and group B is considered as the control that will recive placebo. In order to concealment of the balanced block randomization method, the drug and placebo are made in the same package by the pharmaceutical company and will be provided to a member of the study team who will encode them in a sequence of numbers according to the balanced block randomization list. patients who meet all eligibility criteria will receive the coded drug. Except for the above person, all members of the research team and participants were blinded to the allocation list.

Sorafenib (Soranex)® and placebo are made in the form of similar tablets by the pharmaceutical company. Only one person on the study team who is responsible for randomization takes the tables, puts them in similar packages and encodes as a sequence of numbers according to a list of Balanced Block Randomization. Upon arrival of the each eligible patient, the coded package will be provided with a label that includes the drug numerical code, patient name, and study code. Except for the above person, no body, including the treating physician, the person in charge of data collection and analysis, statistical analyzer, and the patient himself, are aware of the type of drug. Allocation concealment samples are done by the people of the center that they and patients do not have any information about the researcher's aim.

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