Sorafenib to Treat FLT3-ITD AML

Soochow University

Status: Unknown

Conditions: FLT3-ITD Mutation; Acute Myeloid Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT02156297

SZ3201

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 5 patient groups

Induction Group

Consolidation Group

Salvage Group

Maintenance Group

Alleviatitive Group