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

• Status: Completed
• Trial end date: 2019-08-10
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: First People's Hospital of Chenzhou; Fujian Medical University; Guangdong General Hospital; Guangzhou First Municipal People’s Hospital; Guangzhou General Hospital of Guangzhou Military; Peking University People's Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The First Affiliated Hospital of Guangzhou Medical University; Third Affiliated Hospital, Sun Yat-Sen University; Xiangya Hospital of Central South University; Zhujiang Hospital
• Treatments: Niacinamide; Sorafenib

Criteria

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)