Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia
NCT04674345 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 346
Last updated 2021-11-08
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.
Conditions
- Acute Leukemia
- Relapse
- Hematopoietic Stem Cell Transplantation
Interventions
- DRUG
-
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).
Sponsors & Collaborators
-
Peking University People's Hospital
collaborator OTHER -
Xiangya Hospital of Central South University
collaborator OTHER -
Zhujiang Hospital
collaborator OTHER -
Third Affiliated Hospital, Sun Yat-Sen University
collaborator OTHER -
First People's Hospital of Chenzhou
collaborator OTHER -
The First Affiliated Hospital of Guangzhou Medical University
collaborator OTHER -
The Third Xiangya Hospital of Central South University
collaborator OTHER -
Second Affiliated Hospital, Sun Yat-Sen University
collaborator OTHER -
The Seventh Affiliated Hospital of Sun Yat-sen University
collaborator OTHER -
Nanfang Hospital, Southern Medical University
lead OTHER
Principal Investigators
-
Qifa Liu · Nanfang Hospital, Southern Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-15
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
Countries
- China
Study Locations
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