Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)
m-FLAI
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)
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 17, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedNovember 24, 2010
November 1, 2010
2 years
November 17, 2010
November 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete remission rate
Rate of complete remssion (CR) after two cycles of m-FLAI induction
Secondary Outcomes (4)
Rate of serious adverse events (SAE)
Event Free Survival
overall survival
Predictive factors for Complete remission
Interventions
fludarabine, cytarabine, idarubicin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Kim 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: 23077109DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inho Kim
professor
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 17, 2010
First Posted
November 24, 2010
Study Start
June 1, 2007
Primary Completion
June 1, 2009
Study Completion
July 1, 2010
Last Updated
November 24, 2010
Record last verified: 2010-11