Clinical trial · Interventional
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)
NCT01247493CI-TRIAL-00004129m-FLAIcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| induction chemotherapy (fludarabine, cytarabine, idarubicin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete remission rate
- description
- Rate of complete remssion (CR) after two cycles of m-FLAI induction
Secondary outcomes (4)
- measure
- Rate of serious adverse events (SAE)
- description
- Number of patients dying from SAE related to m-FLAI induction
- measure
- Event Free Survival
- description
- Event free survival defined as a period from study enrollment to death by from cause or relapse of disease after complete remission
- measure
- overall survival
- description
- Overall survival defined as a period from study enrollment to death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim I, Koh Y, Yoon SS, Park S, Kim BK, Kim DY, Lee JH, Lee KH, Cheong JW, Lee HK, Kim SH, Kim H, Joo YD, Lee SM, Won JH, Park SK, Hong DS, Kim SH, Sohn SK, Kim CS, Park E, Kim MK, Park MR, Lee JH, Min YH; Korean Society of Hematology AML/MDS working party. Fludarabine, cytarabine, and attenuated-dose idarubicin (m-FLAI) combination therapy for elderly acute myeloid leukemia patients. Am J Hematol. 2013 Jan;88(1):10-5. doi: 10.1002/ajh.23337. Epub 2012 Oct 17. PMID 23077109