Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allo-HSCT for Patients With FLT3-ITD AML

Nanfang Hospital, Southern Medical University

Status

Completed

Conditions

Acute Myeloid Leukemia With FLT3/ITD Mutation

Hematopoietic Stem Cell Transplantation

Acute Myeloid Leukemia

Treatments

Drug: Sorafenib

Study type

Observational

Funder types

Other

Identifiers

NCT04788420

Sorafenib-Flt3 AML-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

456 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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)