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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04674345
Other study ID # Sorafenib-Non-Flt3 AL-2020
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 15, 2020
Est. completion date December 31, 2023

Study information

Verified date December 2020
Source Nanfang Hospital of Southern Medical University
Contact Li Xuan
Phone +86-020-62787883
Email 356135708@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 346
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sorafenib
The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity (dose range, 200-800 mg daily).

Locations

Country Name City State
China Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (10)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University First People's Hospital of Chenzhou, Peking University People's Hospital, Second 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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of leukemia relapse 1 year
Secondary Overall survival 1 year
Secondary Leukemia-free survival 1 year
Secondary Adverse effects 1 year
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