Status:

COMPLETED

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

Lead Sponsor:

Nanfang Hospital, Southern Medical University

Collaborating Sponsors:

Peking University People's Hospital

Third Affiliated Hospital, Sun Yat-Sen University

Conditions:

Acute Myeloid Leukemia

Acute Myeloid Leukemia With FLT3/ITD Mutation

Eligibility:

All Genders

18-60 years

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-I...

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 infer...

Eligibility Criteria

Inclusion

  • FLT3-ITD Positive AML
  • Allo-HSCT Recipients

Exclusion

  • 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)

Key Trial Info

Start Date :

January 1 2012

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2020

Estimated Enrollment :

456 Patients enrolled

Trial Details

Trial ID

NCT04788420

Start Date

January 1 2012

End Date

December 31 2020

Last Update

June 1 2022

Active Locations (1)

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Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510515