Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allo-HSCT for Patients With FLT3-ITD AML
1 other identifier
observational
456
1 country
1
Brief Summary
The purpose of this study is to reveal the influence of co-existing mutations on the efficacy of sorafenib maintenance after allogeneic hematopoietic stem cell transplantation for patients with FLT3-ITD AML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
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
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFirst Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 9, 2021
CompletedJune 1, 2022
May 1, 2022
6.6 years
March 5, 2021
May 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of leukemia relapse
2 year
Secondary Outcomes (2)
Overall survival
2 year
Leukemia-free survival
2 year
Study Arms (2)
Sorafenib group
Patients assigned to this group received sorafenib post-transplantation.
Control group
Patients assigned to this group did not receive sorafenib or any other FLT3 inhibitor post-transplantation until reaching the primary outcome.
Interventions
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
Cases included in this study were from 4 previously published studies of our study group, including 3 retrospective and 1 prospective studies.
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 (according to the 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
- Institute of Hematology & Blood Diseases Hospital, Chinacollaborator
- The First Affiliated Hospital of Soochow Universitycollaborator
- Xinqiao Hospital of Chongqingcollaborator
- First Affiliated Hospital of Zhejiang Universitycollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (4)
Xuan L, Wang Y, Huang F, Jiang E, Deng L, Wu B, Fan Z, Liang X, Xu N, Ye J, Lin R, Yin C, Zhang Y, Sun J, Han M, Huang X, Liu Q. Effect of sorafenib on the outcomes of patients with FLT3-ITD acute myeloid leukemia undergoing allogeneic hematopoietic stem cell transplantation. Cancer. 2018 May 1;124(9):1954-1963. doi: 10.1002/cncr.31295. Epub 2018 Mar 6.
PMID: 29509276BACKGROUNDXuan 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: 32791048BACKGROUNDXuan L, Wang Y, Chen J, Jiang E, Gao L, Wu B, Deng L, Liang X, Huang F, Fan Z, Tang X, Sun J, Zhang X, Han M, Wu D, Huang X, Liu Q. Sorafenib Therapy Is Associated with Improved Outcomes for FMS-like Tyrosine Kinase 3 Internal Tandem Duplication Acute Myeloid Leukemia Relapsing after Allogeneic Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2019 Aug;25(8):1674-1681. doi: 10.1016/j.bbmt.2019.04.018. Epub 2019 Apr 19.
PMID: 31009704BACKGROUNDShi J, Cao L, Luo Y, Zhao Y, Tan Y, Yu J, Lai X, Zhu Y, Hu Y, He J, Sun J, Zheng W, Wei G, Huang H. Maintenance sorafenib is superior to prophylactic donor lymphocyte infusion at improving the prognosis of acute myeloid leukemia with FMS-like tyrosine kinase 3 internal tandem duplication after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 Jan;56(1):293-296. doi: 10.1038/s41409-020-01015-w. Epub 2020 Aug 4. No abstract available.
PMID: 32753705BACKGROUND
Biospecimen
Bone marrow and/or peripheral blood were taken from participants upon enrollment for diagnosis and detection of co-occurring mutations via PCR, direct sequencing and /or new generation sequencing.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu, MD
Nanfang Hospital, Southern Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 9, 2021
Study Start
January 1, 2012
Primary Completion
July 21, 2018
Study Completion
December 31, 2020
Last Updated
June 1, 2022
Record last verified: 2022-05