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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00559221
First Posted: November 16, 2007
Last Update Posted: October 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cooperative Study Group A for Hematology
  Purpose
- 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

Condition Intervention Phase
Acute Myeloid Leukemia Drug: FLAG+IDA Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:
  • Complete remission rate, duration of complete remission, toxicities [ Time Frame: 06/2008 ]

Secondary Outcome Measures:
  • progression-free survival, overall survival [ Time Frame: 06/2008 ]

Estimated Enrollment: 37
Study Start Date: December 2004
Estimated Study Completion Date: June 2008
Arms Assigned Interventions
No Intervention: 1 Drug: FLAG+IDA
Fludarabine, cytarabine, G-CSF

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559221


Contacts
Contact: Yae-Eun Jang, nurse 80-2-3010-7290 redpin75@paran.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yae-Eun , Jang    82-2-3010-7290    redpin75@paran.com   
Principal Investigator: Hawk Kim, professor         
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
Principal Investigator: Hawk Kim, professor Ulsan Universtity Hospital, ROK
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00559221     History of Changes
Other Study ID Numbers: C-007A
First Submitted: November 15, 2007
First Posted: November 16, 2007
Last Update Posted: October 15, 2008
Last Verified: November 2007

Keywords provided by Cooperative Study Group A for Hematology:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Cytarabine
Lenograstim
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic