IRCT20140818018842N21
Recruiting
Phase 3
A Pilot Study of Sorafenib (Soranex)® (FLT3 Inhibitor) Administeration as Maintenance Therapy Following Allogeneic Transplant for AML Patients with FLT3/ITD mutation
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 20
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 55 years (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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