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

Acute Leukemia Clinical Trial

Official title:

Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3 Negative Acute Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04674345
• Other study ID #: Sorafenib-Non-Flt3 AL-2020
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Hematopoietic Stem Cell Transplantation
• Leukemia
• Recurrence
• Relapse

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