Sorafenib to Treat FLT3-ITD AML | NCT02156297

Studies
Sorafenib to Treat FLT3-ITD AML

NCT02156297

Sponsor

The First Affiliated Hospital of Soochow University

Status

Unknown status

Last Update Posted

Feb 5, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Myeloid Leukemia
FLT3-ITD Mutation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

May 2020Estimated

Completion Date

Aug 2022Estimated

First Submitted Date

May 30, 2014

First Submission Date that Met QC Criteria

Jun 3, 2014

First Posted Date

Jun 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2020

Last Update Posted Date

Feb 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jia Chen, M.D.	Contact	+86 512 67781856		c_jerry_j@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Soochow University	Recruiting	Suzhou	Jiangsu	215006	China

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Induction Group
Consolidation Group
Salvage Group
Maintenance Group
Alleviatitive Group