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IRCT20140818018842N21 IRCT 2021-12-26 Tehran University of Medical Sciences Sorafenib (Soranex)® for prevention of relapse in AML Patients A Pilot Study of Sorafenib (Soranex)® (FLT3 Inhibitor) Administeration as Maintenance Therapy Following Allogeneic Transplant for AML Patients with FLT3/ITD mutation 2021-02-19 anticipated 20 Complete https://irct.ir/trial/51106 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Acute myeloblastic leukemia. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Maryam Barkhordar
Shariati Hospital, North Kargar Ave.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2635 barkhordarm.n@gmail.com Tehran University of Medical Sciences scientific Maryam Barkhordar
Shariati Hospital, Kaargar shomali Ave.
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8490 2635 barkhordarm.n@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Subjects with AML with the FLT3-ITD mutation who have undergone allogeneic HSCT Peripheral blood chimerism studies showing >/= 90% of all cells are of donor origin ECOG performance status 0-2 Able to swallow whole pills Adequate hematologic and hepatic function 18 years 55 years Both Evidence of relapsed/recurrent/residual disease as assessed by bone marrow aspirate and biopsy performed between days 30-60 after HSCT Active acute graft vs host disease requiring an equivalent dose of > 0.5 mg/kg/day of prednisone Ongoing uncontrolled infection Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Known HIV infection or chronic hepatitis B or C Any other hemorrhage/bleeding or dermal complication related to intervention CTCAE v. 4.0 > = Grade 3 within 4 weeks of starting study drug Receiving any other investigational agents C92.0 Acute myeloblastic leukemia Treatment - Drugs Placebo 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. Cumulative incidence Relaps. Timepoint: 1 year. Method of measurement: Patient follow up for absent of relapse by Bone Marrow aspiration and biopsy, Physical exam and lab test. One year relapse free survival (RFS). Timepoint: 1 year. Method of measurement: Patient follow up for absent of relapse by Bone Marrow aspiration and biopsy, Physical exam and lab test. One year overal survival (OS). Timepoint: 1 year. Method of measurement: Follow up visit. Cumulative incidence acute GvHD. Timepoint: After 100 daye post HSCT. Method of measurement: Physical exam and lab test. Noavaran Daroui Kimia Tehran University of Medical Sciences Noavaran Daroui Kimia Approved 2020-07-01 Ethic committee of Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran Univer Kargar shomali Ave., Shariati hospital Tehran Tehran Iran (Islamic Republic of)