Sorafenib to Treat FLT3-ITD AML

February 3, 2020 updated by: The First Affiliated Hospital of Soochow University

Sorafenib to Treat AML Patients With FLT3-ITD Mutation: a Non-interventional Cohort Study

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • the First Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who diagnosed as AML with FLT3-ITD mutation and accepting the prescription of sorafenib.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Induction Group
Consolidation Group
Salvage Group
Maintenance Group
Alleviatitive Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate
Time Frame: up to 2 years
up to 2 years
Progress-Free Survival
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: up to 2 years
up to 2 years
Leukemia-Free Survival
Time Frame: up to 2 years
up to 2 years
Median time to the onset of sorafenib resistance
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (ESTIMATE)

June 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SZ3201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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