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

Nanfang Hospital, Southern Medical University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Acute Leukemia

Hematopoietic Stem Cell Transplantation

Relapse

Treatments

Drug: Sorafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT04674345

Sorafenib-Non-Flt3 AL-2020

Details and patient eligibility

About

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

Full description

Sorafenib is a multikinase inhibitor that blocks multiple pathways involved in the development and progression of acute leukemia, such as FLT3-ITD, the RAS and RAF gene families, KIT, and the VEGF and PDGF receptors. Recently, two back-to-back randomized controlled trials both reveal that sorafenib maintenance after allo-HSCT could prevent relapse in patients with FLT3-ITD AML, resulting in a survival benefit. Sorafenib has also been explored in the treatment of acute leukemia without FLT3 mutations and shown promising results. Currently, relapse remains the major cause of transplant failure, especially for high-risk and refractory acute leukemia patients. Once patients relapse after allo-HSCT, the prognosis is dismal. Therefore, prevention of relapse is of great importance to improve the prognosis. Based on the current research status, we plan to conduct a prospective, multicenter, phase 2 randomized controlled trial to explore the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.

Enrollment

346 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)