Efficacy of FLAG Regimen for the Treatment of Patients With AML

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03600558
• Other study ID #: Handong
• Status: Recruiting
• Start date: November 21, 2018
• Est. completion date: July 2020

Study information

• Verified date: April 2020
• Source: Tianjin Medical University General Hospital
• Contact: Zonghong Shao, MD
• Phone: 8602260817092
• Email: shaozonghong[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient more than 18 year old

• De novo or secondary leukemia.

• Treated with FLAG regimen

Exclusion Criteria:

• Acute promyelocytic leukemia (APL)

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Severe adverse events	Severe adverse events during consolidation treatment	45 days
Secondary	Complete Remission Rate		2 months
Secondary	Event-Free Survival Rate		2 years