NCT00559221

Brief Summary

\- 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 15, 2008

Status Verified

November 1, 2007

First QC Date

November 15, 2007

Last Update Submit

October 13, 2008

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

  • Complete remission rate, duration of complete remission, toxicities

    06/2008

Secondary Outcomes (1)

  • progression-free survival, overall survival

    06/2008

Study Arms (1)

1

NO INTERVENTION
Drug: FLAG+IDA

Interventions

FLAG+IDADRUG

Fludarabine, cytarabine, G-CSF

1

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • and 60 years of age.
  • or less by ECOG performance scale.

You may not qualify if:

  • acute promyelocytic leukemia
  • pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25891993DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Ida-FLAG protocol

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Hawk Kim, professor

    Ulsan Universtity Hospital, ROK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yae-Eun Jang, nurse

CONTACT

80-2-3010-7290redpin75@paran.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

December 1, 2004

Study Completion

June 1, 2008

Last Updated

October 15, 2008

Record last verified: 2007-11

Locations

KR(1)