Acute myeloblastic leukemia. Acute myeloblastic leukemia
Conditions
Interventions
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
Sponsors
Tehran University of Medical Sciences
Noavaran Daroui Kimia
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Barkhordar
Tehran University of Medical Sciences
Outcome results
None listed