Sorafenib for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3-ITD Positive Acute Myeloid Leukemia
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- Incidence of leukemia relapse
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD positive acute myeloid leukemia (AML).
Detailed Description
Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been reported in 20%-30% of patients with acute myeloid leukemia (AML). FLT3-ITD-positive AML patients have an inferior survival, primarily due to lower complete remission (CR) rate and higher relapse rate. Although allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the outcomes of some FLT3-ITD-positive AML, a significant number will suffer disease recurrence after allo-HSCT. Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. Recent studies have shown that sorafenib monotherapy or in combination with chemotherapy are effective in attaining CR, but they do not have significant improvement in relapse. Currently, prophylactic use of sorafenib after allo-HSCT has been rarely reported, and whether it can improve outcomes of FLT3-ITD-positive AML remains unclear.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •FLT3-ITD Positive AML
- •Allo-HSCT Recipients
Exclusion Criteria
- •cardiac dysfunction (particularly congestive heart failure)
- •hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
- •renal dysfunction (creatinine clearance rate \< 30 mL/min)
- •Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- •Patients with any conditions not suitable for the trial (investigators' decision)
Arms & Interventions
Sorafenib group
Sorafenib will be used from day 30 to 180 post-transplantation.
Intervention: Sorafenib (Drug)
Outcomes
Primary Outcomes
Incidence of leukemia relapse
Time Frame: 1 year
Secondary Outcomes
- Overall survival(3 year)
- leukemia-free survival(3 year)
- Incidence of side effect of sorafenib(6 months)
Investigators
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University