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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01247493
First received: November 17, 2010
Last updated: November 23, 2010
Last verified: November 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247493

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

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kim, Inho professor, SeoulNUH
ClinicalTrials.gov 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:
fludarabine
AML
Efficacy
tolerability

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Fludarabine monophosphate
Fludarabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
 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

ClinicalTrials.gov processed this record on May 19, 2013