Sorafenib to Treat FLT3-ITD AML

• Conditions: Acute Myeloid Leukemia; FLT3-ITD Mutation

• Registration Number: NCT02156297
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. The duration of the study from June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The inclusion criteria is:

1. Definitely diagnosed as AML

2. FLT3-ITD mutation has been confirmed

3. Accepting the prescription of sorafenib

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-30
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-05
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Definitely diagnosed as AML
• FLT3-ITD mutation has been confirmed
• Accepting the prescription of sorafenib

Exclusion Criteria

• Can not take drugs orally
• Can not follow the doctors' advices
• Other reasons that investigators considered as contra-indications for this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	up to 2 years
Progress-Free Survival	up to 2 years

Secondary Outcome Measures

Name	Time	Method
Leukemia-Free Survival	up to 2 years
Median time to the onset of sorafenib resistance	up to 2 years
Overall Survival	up to 2 years

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China