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

NCT ID: NCT01247493

Last Updated: 2010-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Keywords

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fludarabine AML Efficacy tolerability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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induction chemotherapy (fludarabine, cytarabine, idarubicin)

fludarabine, cytarabine, idarubicin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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SeoulNUH

Principal Investigators

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Inho Kim

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 23077109 (View on PubMed)

Other Identifiers

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H-0704-029-205

Identifier Type: -

Identifier Source: org_study_id