Sorafenib (Soranex)® for prevention of relapse in AML Patients
- Conditions
- Acute myeloblastic leukemia.Acute myeloblastic leukemiaC92.0
- Registration Number
- IRCT20140818018842N21
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.