Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML
NCT02474290 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 202
Last updated 2019-08-26
Summary
The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD positive acute myeloid leukemia (AML).
Conditions
- Acute Myeloid Leukemia
- 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 or resistance (dose range, 200-800 mg daily).
Sponsors & Collaborators
-
Peking University People's Hospital
collaborator OTHER -
Third Affiliated Hospital, Sun Yat-Sen University
collaborator OTHER -
Zhujiang Hospital
collaborator OTHER -
Xiangya Hospital of Central South University
collaborator OTHER -
First People's Hospital of Chenzhou
collaborator OTHER -
The First Affiliated Hospital of Guangzhou Medical 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
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-20
- Primary Completion
- 2018-07-21
- Completion
- 2019-08-10
Countries
- China
Study Locations
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