Efficacy of FLAG Regimen for the Treatment of Patients Wi... | NCT03600558

Studies
Efficacy of FLAG Regimen for the Treatment of Patients With AML

NCT03600558

Sponsor

Tianjin Medical University General Hospital

Status

Unknown status

Last Update Posted

Apr 24, 2020Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

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

Apr 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

Nov 21, 2018Actual

Primary Completion Date

Jul 2020Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Jul 17, 2018

First Submission Date that Met QC Criteria

Jul 24, 2018

First Posted Date

Jul 26, 2018Actual

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

Apr 23, 2020

Last Update Posted Date

Apr 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ZhongHong Shao, head of department of Hematology, Tianjin Medical University General HospitalPrincipal Investigator

Lead Sponsor

Tianjin Medical University General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

The long-term efficacy of chemotherapy in patients with acute myeloid leukemia (AML) has been significantly improved in recent years. The combination of anthracycline plus cytarabine (Ara-C) has been a standard induction regimen for patients with AML. However, the optimal consolidation therapy after induction chemotherapy has not reached a consensus. The FLAG regimen consisting of fludarabine and high-dose cytarabine combined with G-CSF which is one of the first-line consolidation treatment options for relapsed and refractory AML. This study conducted a retrospective analysis of the intensive treatment of AML with the FLAG regimen from January 2007 to May 2018 in our hospital to evaluate the efficacy of the FLAG regimen. To provide the basis for the choice and timing of treatment for patients with AML treated with the FLAG regimen.

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

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	For evaluating the FLAG effect, OS was defined from consolidation randomization to death from any cause (censored at last contact).	3 years

Secondary Outcomes

Measure	Description	Time Frame
Relapse-free survival	Relapse Free Survival defined as the time from onset of FLAG treatment for AML to the first event (death or relapse).	2 years
Severe adverse events	Severe adverse events during consolidation treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient more than 18 year old
De novo or secondary leukemia.
Treated with FLAG regimen

Exclusion Criteria:

Acute promyelocytic leukemia (APL)

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

Retrospective cohort, using medical charts of AML patients treated with the FLAG regimen from January 2007 to May 2018

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zonghong Shao, MD	Contact	8602260817092		shaozonghong@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Medical University General Hospital	Recruiting	Tianjin	Tianjin Municipality	300000	China

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D007951	Leukemia, Myeloid
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided