Efficacy of FLAG Regimen for the Treatment of Patients With AML

• Conditions: Leukemia, Myeloid; Leukemia; Leukemia, Myeloid, Acute

• Registration Number: NCT03600558
• Lead Sponsor: Tianjin Medical University General Hospital

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 available

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Study Start: 2018-11-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Acute promyelocytic leukemia (APL)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China