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Status unknownNCT02156297Updated Feb 5, 2020

Sorafenib to Treat FLT3-ITD AML

An observational study in Acute Myeloid Leukemia and FLT3-ITD Mutation, sponsored by The First Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by The First Affiliated Hospital of Soochow University · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Acute Myeloid Leukemia
  • FLT3-ITD Mutation
03

In context

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Can not take drugs orally
  • Can not follow the doctors' advices
  • Other reasons that investigators considered as contra-indications for this study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Induction Group
  • Consolidation Group
  • Salvage Group
  • Maintenance Group
  • Alleviatitive Group
06

What researchers measure

Primary outcomes

  1. Overall Response Rate

    Time frame: up to 2 years

  2. Progress-Free Survival

    Time frame: up to 2 years

Secondary outcomes

  1. Overall Survival

    Time frame: up to 2 years

  2. Leukemia-Free Survival

    Time frame: up to 2 years

  3. Median time to the onset of sorafenib resistance

    Time frame: up to 2 years

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
    • Jia Chen, M.D. · Contact · c_jerry_j@163.com · +86 512 67781856
    • Depei Wu, M.D., Ph.D. · Principal investigator
    • Jia Chen, M.D. · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02156297
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Jun 5, 2014
Start date
Jun 2014
Primary completion
May 2020 (estimated)
Completion
Aug 2022 (estimated)
Last update
Feb 5, 2020

Study contacts

Jia Chen, M.D.
Contact
c_jerry_j@163.com
+86 512 67781856

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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