- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788420
Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allo-HSCT for Patients With FLT3-ITD AML
May 30, 2022 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University
Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for Patients With FLT3-ITD Positive Acute Myeloid Leukemia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been reported in 20%-30% of patients with acute myeloid leukemia (AML).
FLT3-ITD-positive AML patients have an inferior survival, primarily due to lower complete remission (CR) rate and higher relapse rate.
Our previous studies demonstrated that post-transplantation sorafenib maintenance could improve the outcomes of FLT3-ITD-positive AML patients.
However, whether other co-existing mutations influence the efficacy of post-allo-HSCT sorafenib maintenance remains unknown.
Study Type
Observational
Enrollment (Actual)
456
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Department of Hematology,Nanfang Hospital, Southern Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cases included in this study were from 4 previously published studies of our study group, including 3 retrospective and 1 prospective studies.
Description
Inclusion Criteria:
- FLT3-ITD Positive AML
- Allo-HSCT Recipients
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Sorafenib group
Patients assigned to this group received sorafenib post-transplantation.
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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).
Other Names:
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Control group
Patients assigned to this group did not receive sorafenib or any other FLT3 inhibitor post-transplantation until reaching the primary outcome.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of leukemia relapse
Time Frame: 2 year
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2 year
|
2 year
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Leukemia-free survival
Time Frame: 2 year
|
2 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Xuan 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.
- Xuan 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.
- Shi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
July 21, 2018
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
March 5, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 9, 2021
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 30, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sorafenib-Flt3 AML-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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