Acute Myeloid Leukemia, Acute Myeloid Leukemia With FLT3/ITD Mutation, Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Acute Myeloid Leukemia, FLT3-ITD, Hematopoietic Stem Cell Transplantation, sorafenib
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.
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.
Interventions
DRUGSorafenib
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
Peking University People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
Xiangya Hospital of Central South University
First People's Hospital of Chenzhou
The First Affiliated Hospital of Guangzhou Medical University
Institute of Hematology & Blood Diseases Hospital, China
The First Affiliated Hospital of Soochow University
Xinqiao Hospital of Chongqing
First Affiliated Hospital of Zhejiang University
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of leukemia relapse | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 2 year |
| Leukemia-free survival | 2 year |
Countries
China
Outcome results
None listed