Back to resultsModified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML) (m-FLAI)
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
induction chemotherapy (fludarabine, cytarabine, idarubicin)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring fludarabine, AML, Efficacy, tolerability
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Outcomes
Primary Outcome Measures
Complete remission rate
Rate of complete remssion (CR) after two cycles of m-FLAI induction
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01247493
First Posted
November 17, 2010
Last Updated
November 23, 2010
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01247493
Brief Title
Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)
Acronym
m-FLAI
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
fludarabine, AML, Efficacy, tolerability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
induction chemotherapy (fludarabine, cytarabine, idarubicin)
Intervention Description
fludarabine, cytarabine, idarubicin
Primary Outcome Measure Information:
Title
Complete remission rate
Description
Rate of complete remssion (CR) after two cycles of m-FLAI induction
Secondary Outcome Measure Information:
Title
Rate of serious adverse events (SAE)
Description
Number of patients dying from SAE related to m-FLAI induction
Title
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
Title
overall survival
Description
Overall survival defined as a period from study enrollment to death from any cause
Title
Predictive factors for Complete remission
Description
Compare complete remission rate according to existence of specific chromosome abnormality and Charlson comorbidity index to evaluate predicative impact of these factors.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inho Kim
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23077109
Citation
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.
Results Reference
derived
Learn more about this trial
Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)
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