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Completed

NCT Number: NCT04788420

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Acute Myeloid Leukemia With FLT3/ITD Mutation Hematologic Diseases Hematopoietic Stem Cell Transplantation Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sorafenib

Drug

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: Nexavar, BAY 43-9006, BAY-673472, BAY 545-9085

Primary outcomes

  1. Incidence of leukemia relapse

    Time frame: 2 year

Secondary outcomes

  1. Overall survival

    Time frame: 2 year

  2. Leukemia-free survival

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • First Affiliated Hospital of Zhejiang University
  • First People's Hospital of Chenzhou
  • Institute of Hematology & Blood Diseases Hospital, China
  • Peking University People's Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of Soochow University
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Xiangya Hospital of Central South University
  • Xinqiao Hospital of Chongqing
  • Zhujiang Hospital

Registry information

Official study title

Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for Patients With FLT3-ITD Positive Acute Myeloid Leukemia

Important dates

Study start
2012
Primary completion
2018
Study completion
2020
First posted
Mar 9, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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