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

October 13, 2008 updated by: Cooperative Study Group A for Hematology

Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia

- 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Hawk Kim, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Drug: FLAG+IDA
Fludarabine, cytarabine, G-CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete remission rate, duration of complete remission, toxicities
Time Frame: 06/2008
06/2008

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival, overall survival
Time Frame: 06/2008
06/2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cooperative Study Group A for Hematology

Investigators

  • Principal Investigator: Hawk Kim, professor, Ulsan Universtity Hospital, ROK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

October 15, 2008

Last Update Submitted That Met QC Criteria

October 13, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-007A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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