FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML

NCT ID: NCT00559221

Last Updated: 2008-10-15

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-06-30

Brief Summary

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\- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia

Detailed Description

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\- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Conditions

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Acute Myeloid Leukemia

Keywords

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AML

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type NO_INTERVENTION

FLAG+IDA

Intervention Type DRUG

Fludarabine, cytarabine, G-CSF

Interventions

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FLAG+IDA

Fludarabine, cytarabine, G-CSF

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.
* Early relapse, occurring after a first CR lasting less than 12 months.
* Patients with multiple relapses will be included.
* Written informed consent must be given.
* 15 and 60 years of age.
* 2 or less by ECOG performance scale.

Exclusion Criteria

* acute promyelocytic leukemia
* pregnant or lactating
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cooperative Study Group A for Hematology

NETWORK

Sponsor Role lead

Principal Investigators

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Hawk Kim, professor

Role: PRINCIPAL_INVESTIGATOR

Ulsan Universtity Hospital, ROK

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yae-Eun Jang, nurse

Role: CONTACT

Phone: 80-2-3010-7290

Email: [email protected]

Facility Contacts

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Yae-Eun, Jang

Role: primary

References

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Kim H, Lee JH, Joo YD, Bae SH, Lee JH, Kim DY, Lee WS, Ryoo HM, Jo JC, Choi Y, Lee KH; CoOperative Study Group A for Hematology (COSAH). A prospective, multicenter phase II study of continuous infusion of FLAG for patients older than 60 yr with resistant acute myeloid leukemia: a comparison with intensive younger patients' trial. Eur J Haematol. 2016 Feb;96(2):188-97. doi: 10.1111/ejh.12568. Epub 2015 May 6.

Reference Type DERIVED
PMID: 25891993 (View on PubMed)

Other Identifiers

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C-007A

Identifier Type: -

Identifier Source: org_study_id