Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)

Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01247493

Acronym

m-FLAI

Enrollment

108

Registered

2010-11-24

Start date

2007-06-30

Completion date

2010-07-31

Last updated

2010-11-24

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

Conditions

Acute Myeloid Leukemia

Keywords

fludarabine, AML, Efficacy, tolerability

Brief summary

A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute myeloid leukemia.

Interventions

DRUGinduction chemotherapy (fludarabine, cytarabine, idarubicin)

fludarabine, cytarabine, idarubicin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

* previously untreated AML (excluding acute promyelocytic leukemia) * age greater than 60 years old * ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2 * adequate hepatic/ renal/ cardiac function

Exclusion criteria

* acute promyelocytic leukemia * significant cardiac disease * combined non-hematologic malignancy * aleukemic leukemia (only granulocytic sarcoma) * CNS (Central Nervous system) involvement * significant comorbidity/ uncontrollable bleeding tendency

Design outcomes

Primary

Measure	Time frame	Description
Complete remission rate	—	Rate of complete remssion (CR) after two cycles of m-FLAI induction

Secondary

Measure	Time frame	Description
Rate of serious adverse events (SAE)	—	Number of patients dying from SAE related to m-FLAI induction
Event Free Survival	—	Event free survival defined as a period from study enrollment to death by from cause or relapse of disease after complete remission
overall survival	—	Overall survival defined as a period from study enrollment to death from any cause
Predictive factors for Complete remission	—	Compare complete remission rate according to existence of specific chromosome abnormality and Charlson comorbidity index to evaluate predicative impact of these factors.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026