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

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ClinicalTrials.gov Identifier: NCT00559221
Recruitment Status : Unknown
Verified November 2007 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
First Posted : November 16, 2007
Last Update Posted : October 15, 2008
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: FLAG+IDA Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
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
Study Start Date : December 2004
Estimated Study Completion Date : June 2008


Arms and Interventions

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


Outcome Measures

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

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

Eligibility Criteria

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 Posted: November 16, 2007    Key Record Dates
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