Efficacy of FLAG Regimen for the Treatment of Patients With AML

Efficacy of Fludarabine, Cytarabine and G-CSF (FLAG Regimen) for the Treatment of Patients With Acute Myeloid Leukemia (AML)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03600558

Enrollment

Registered

2018-07-26

Start date

2018-11-21

Completion date

2020-07-31

Last updated

2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute

Keywords

FLAG

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Acute promyelocytic leukemia (APL)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Relapse-free survival	2 years	Relapse Free Survival defined as the time from onset of FLAG treatment for AML to the first event (death or relapse).
Severe adverse events	45 days	Severe adverse events during consolidation treatment
Complete Remission Rate	2 months	—
Event-Free Survival Rate	2 years	—

Countries

China

Contacts

Primary ContactZonghong Shao, MD

shaozonghong@sina.com8602260817092

Outcome results