NCT03600558

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.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

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

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

July 17, 2018

Last Update Submit

April 23, 2020

Conditions

LeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute

Keywords

FLAG

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • Relapse-free survival

    2 years

  • Severe adverse events

    45 days

  • Complete Remission Rate

    2 months

  • Event-Free Survival Rate

    2 years

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Acute promyelocytic leukemia (APL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

LeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Zonghong Shao, MD

CONTACT

8602260817092shaozonghong@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of department of Hematology

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

November 21, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

CN(1)