Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML

Phase 2

Completed

• Conditions: Hematopoietic Stem Cell Transplantation; Acute Myeloid Leukemia
• Interventions: Drug: Sorafenib

• Registration Number: NCT02474290
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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 Timeline

• Status Verified: 2015-06
• Study First Submitted: 2015-06-14
• Study First Submitted QC: 2015-06-14
• Study First Posted: 2015-06-17
• Study Start: 2015-06-20
• Primary Completion: 2018-07-21
• Study Completion: 2019-08-10
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib group	Sorafenib	Sorafenib will be used from day 30 to 180 post-transplantation.

Primary Outcome Measures

Name	Time	Method
Incidence of leukemia relapse	1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 year
leukemia-free survival	3 year
Incidence of side effect of sorafenib	6 months

Trial Locations

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China