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Completed

NCT Number: NCT01247493

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

induction chemotherapy (fludarabine, cytarabine, idarubicin)

Drug

fludarabine, cytarabine, idarubicin

Primary outcomes

  1. Complete remission rate

    Rate of complete remssion (CR) after two cycles of m-FLAI induction

Secondary outcomes

  1. Rate of serious adverse events (SAE)

    Number of patients dying from SAE related to m-FLAI induction

  2. 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

  3. overall survival

    Overall survival defined as a period from study enrollment to death from any cause

  4. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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)

Acronym: m-FLAI

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Nov 24, 2010
Registry last updated
Nov 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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