Status:
UNKNOWN
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Peking University People's Hospital
Xiangya Hospital of Central South University
Conditions:
Acute Leukemia
Relapse
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT04674345
Start Date
December 15 2020
End Date
December 31 2023
Last Update
November 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515