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

This study has been completed.
Information provided by:
Seoul National University Hospital Identifier:
First received: November 17, 2010
Last updated: November 23, 2010
Last verified: November 2010

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.

Condition Intervention Phase
Acute Myeloid Leukemia
Drug: induction chemotherapy (fludarabine, cytarabine, idarubicin)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Complete remission rate [ Designated as safety issue: No ]
    Rate of complete remssion (CR) after two cycles of m-FLAI induction

Secondary Outcome Measures:
  • Rate of serious adverse events (SAE) [ Designated as safety issue: Yes ]
    Number of patients dying from SAE related to m-FLAI induction

  • Event Free Survival [ Designated as safety issue: No ]
    Event free survival defined as a period from study enrollment to death by from cause or relapse of disease after complete remission

  • overall survival [ Designated as safety issue: No ]
    Overall survival defined as a period from study enrollment to death from any cause

  • Predictive factors for Complete remission [ Designated as safety issue: No ]
    Compare complete remission rate according to existence of specific chromosome abnormality and Charlson comorbidity index to evaluate predicative impact of these factors.

Enrollment: 108
Study Start Date: June 2007
Study Completion Date: July 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: induction chemotherapy (fludarabine, cytarabine, idarubicin)
    fludarabine, cytarabine, idarubicin

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Please refer to this study by its identifier: NCT01247493

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Inho Kim professor
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kim, Inho professor, SeoulNUH Identifier: NCT01247493     History of Changes
Other Study ID Numbers: H-0704-029-205
Study First Received: November 17, 2010
Last Updated: November 23, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Fludarabine monophosphate
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic processed this record on April 16, 2014