NCT02156297

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. 1.Definitely diagnosed as AML
  2. 2.FLT3-ITD mutation has been confirmed
  3. 3.Accepting the prescription of sorafenib

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

5.9 years

First QC Date

May 30, 2014

Last Update Submit

February 3, 2020

Conditions

Acute Myeloid LeukemiaFLT3-ITD Mutation

Outcome Measures

Primary Outcomes (2)

  • Overall Response Rate

    up to 2 years

  • Progress-Free Survival

    up to 2 years

Secondary Outcomes (3)

  • Overall Survival

    up to 2 years

  • Leukemia-Free Survival

    up to 2 years

  • Median time to the onset of sorafenib resistance

    up to 2 years

Study Arms (5)

Induction Group

Consolidation Group

Salvage Group

Maintenance Group

Alleviatitive Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Jia Chen, M.D.

CONTACT

+86 512 67781856c_jerry_j@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 5, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2020

Study Completion

August 1, 2022

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

CN(1)