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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 because the information has not been verified recently.
Verified November 2007 by Cooperative Study Group A for Hematology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT00559221
First received: November 15, 2007
Last updated: October 13, 2008
Last verified: November 2007
History of Changes
  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: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00559221     History of Changes
Other Study ID Numbers: C-007A
Study First Received: November 15, 2007
Last Updated: October 13, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Cooperative Study Group A for Hematology:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Lenograstim
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013