Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.

• 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; Peking University People's Hospital; Second Affiliated Hospital, Sun Yat-Sen University; Seventh Affiliated Hospital, Sun Yat-Sen University; The First Affiliated Hospital of Guangzhou Medical University; The Seventh Affiliated Hospital of Sun Yat-sen University; The Third Xiangya Hospital of Central South University; Third Affiliated Hospital, Sun Yat-Sen University; Xiangya Hospital of Central South University; Zhujiang Hospital
• Treatments: Sorafenib

Criteria

Inclusion Criteria:

• Patients with FLT3-negative acute leukemia undergoing first allo-HSCT

• Age 18 to 65 years old with ECOG performance status 0-2

• Hematopoietic recovery within 60 days post-transplantation

• Sign informed consent form, have the ability to comply with study and follow-up procedures

Exclusion Criteria:

• Acute promyelocytic leukemia (AML subtype M3)

• Acute leukemia with FLT3-ITD or FLT3-TKD mutations

• Philadelphia-positive acute lymphoblastic leukemia

• Chronic myelogenous leukemia with blast crisis

• Intolerance to sorafenib pre-transplantation

• Life expectancy less than 30 days post-transplantation

• Active aGVHD or uncontrolled infections within 60 days post-transplantation

• Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)

• Respiratory failure ( PaO2 ≤60mmHg)

• Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase >2 times the upper limit of normal)

• Renal dysfunction (creatinine clearance rate < 30 mL/min)

• ECOG performance status 3, 4 or 5

• With any conditions not suitable for the trial (investigators' decision)