Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia
NCT ID: NCT04674345
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
346 participants
INTERVENTIONAL
2020-12-15
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sorafenib group
Sorafenib will be administered at 45-60 days post-transplantation and taken for one year.
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).
Non-maintenance group
Neither sorafenib nor other FLT3 inhibitors will be used, unless the patient experiences relapse.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
65 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
Zhujiang Hospital
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
First People's Hospital of Chenzhou
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
The Third Xiangya Hospital of Central South University
OTHER
Second Affiliated Hospital, Sun Yat-Sen University
OTHER
The Seventh Affiliated Hospital of Sun Yat-sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Qifa Liu
Professor
Principal Investigators
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Qifa Liu
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Li Xuan
Role: primary
Other Identifiers
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Sorafenib-Non-Flt3 AL-2020
Identifier Type: -
Identifier Source: org_study_id