Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML
1 other identifier
interventional
202
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedStudy Start
First participant enrolled
June 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2019
CompletedAugust 26, 2019
June 1, 2015
3.1 years
June 14, 2015
August 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of leukemia relapse
1 year
Secondary Outcomes (3)
Overall survival
3 year
leukemia-free survival
3 year
Incidence of side effect of sorafenib
6 months
Study Arms (2)
Sorafenib group
EXPERIMENTALSorafenib will be used from day 30 to 180 post-transplantation.
non-Sorafenib group
NO INTERVENTIONInterventions
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).
Eligibility Criteria
You may qualify if:
- FLT3-ITD Positive AML
- Allo-HSCT Recipients
You may not qualify if:
- cardiac dysfunction (particularly congestive heart failure)
- hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
- renal dysfunction (creatinine clearance rate \< 30 mL/min)
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Peking University People's Hospitalcollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Zhujiang Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- First People's Hospital of Chenzhoucollaborator
- The First Affiliated Hospital of Guangzhou Medical Universitycollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (5)
Ravandi F, Cortes JE, Jones D, Faderl S, Garcia-Manero G, Konopleva MY, O'Brien S, Estrov Z, Borthakur G, Thomas D, Pierce SR, Brandt M, Byrd A, Bekele BN, Pratz K, Luthra R, Levis M, Andreeff M, Kantarjian HM. Phase I/II study of combination therapy with sorafenib, idarubicin, and cytarabine in younger patients with acute myeloid leukemia. J Clin Oncol. 2010 Apr 10;28(11):1856-62. doi: 10.1200/JCO.2009.25.4888. Epub 2010 Mar 8.
PMID: 20212254BACKGROUNDMetzelder SK, Schroeder T, Finck A, Scholl S, Fey M, Gotze K, Linn YC, Kroger M, Reiter A, Salih HR, Heinicke T, Stuhlmann R, Muller L, Giagounidis A, Meyer RG, Brugger W, Vohringer M, Dreger P, Mori M, Basara N, Schafer-Eckart K, Schultheis B, Baldus C, Neubauer A, Burchert A. High activity of sorafenib in FLT3-ITD-positive acute myeloid leukemia synergizes with allo-immune effects to induce sustained responses. Leukemia. 2012 Nov;26(11):2353-9. doi: 10.1038/leu.2012.105. Epub 2012 Apr 16.
PMID: 22504140BACKGROUNDXuan L, Wang Y, Yang K, Shao R, Huang F, Fan Z, Chi P, Xu Y, Xu N, Deng L, Li X, Liang X, Luo X, Shi P, Liu H, Wang Z, Jiang L, Lin R, Chen Y, Tu S, Zhang Y, Sun J, Huang X, Liu Q. Sorafenib maintenance after allogeneic haemopoietic stem-cell transplantation in patients with FLT3-ITD acute myeloid leukaemia: long-term follow-up of an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2023 Aug;10(8):e600-e611. doi: 10.1016/S2352-3026(23)00117-5. Epub 2023 Jul 3.
PMID: 37414062DERIVEDXu X, Fan Z, Wang Y, Huang F, Xu Y, Sun J, Xu N, Deng L, Li X, Liang X, Luo X, Shi P, Liu H, Chen Y, Tu S, Huang X, Liu Q, Xuan L. Effect of sorafenib maintenance on Epstein-Barr virus and cytomegalovirus infections in patients with FLT3-ITD AML undergoing allogeneic hematopoietic stem cell transplantation: a secondary analysis of a randomized clinical trial. BMC Med. 2022 Sep 2;20(1):282. doi: 10.1186/s12916-022-02479-x.
PMID: 36050712DERIVEDXuan L, Wang Y, Huang F, Fan Z, Xu Y, Sun J, Xu N, Deng L, Li X, Liang X, Luo X, Shi P, Liu H, Wang Z, Jiang L, Yu C, Zhou X, Lin R, Chen Y, Tu S, Huang X, Liu Q. Sorafenib maintenance in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1201-1212. doi: 10.1016/S1470-2045(20)30455-1. Epub 2020 Aug 10.
PMID: 32791048DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu
Nanfang Hospital, Southern Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 14, 2015
First Posted
June 17, 2015
Study Start
June 20, 2015
Primary Completion
July 21, 2018
Study Completion
August 10, 2019
Last Updated
August 26, 2019
Record last verified: 2015-06