---
title: Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)
nct_id: NCT01247493
overall_status: COMPLETED
phase: PHASE2
sponsor: Seoul National University Hospital
study_type: INTERVENTIONAL
primary_condition: Acute Myeloid Leukemia
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01247493.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01247493"
ct_last_update_post_date: 2010-11-24
last_seen_at: "2026-05-12T06:39:07.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)

**Official Title:** 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)

**NCT ID:** [NCT01247493](https://clinicaltrials.gov/study/NCT01247493)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 108
- **Lead Sponsor:** Seoul National University Hospital
- **Conditions:** Acute Myeloid Leukemia
- **Start Date:** 2007-06
- **Completion Date:** 2010-07
- **CT.gov Last Update:** 2010-11-24

## 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.

## Eligibility

- **Minimum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **induction chemotherapy (fludarabine, cytarabine, idarubicin)** (DRUG) — fludarabine, cytarabine, idarubicin

## Primary Outcomes

- **Complete remission rate** — Rate of complete remssion (CR) after two cycles of m-FLAI induction

## Secondary Outcomes

- **Rate of serious adverse events (SAE)**
- **Event Free Survival**
- **overall survival**
- **Predictive factors for Complete remission**

## Locations (1)

- Seoul National University Hospital, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.seoul national university hospital|seoul||south korea` — added _(2026-05-12)_

---

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