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A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Cooperative Study Group A for Hematology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT00774332
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL


Condition Intervention Phase
Acute Lymphoblastic Leukemia
 Drug: CODOX-M
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Duration of complete remission, disease-free survival, overall survival, toxicities [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: June 2006
Estimated Study Completion Date: December 2009
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CODOX-M
    Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with relapsed/resistant acute lymphoblastic leukemia
  • Patients must be between 15 and 65 years of age.
  • Estimated life expectancy of more than 3 months
  • ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I)
  • Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan
  • Adequate kidney function (estimated Ccr >50 ml/min)

Exclusion Criteria:

  • Patients with CNS involvement of leukemic blasts will not be excluded.
  • Patients with extramedullary relapse(s) only will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774332

Contacts
Contact: Jung-Hee Lee, doctor 82-2-3010-5794 jhleecr@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jung-Hee Lee, Doctor     82-2-3010-5794     jhleecr@amc.seoul.kr    
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
Principal Investigator: Jung-Hee Lee, Doctor Asan Medical Center
  More Information

No publications provided

Responsible Party: Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT00774332     History of Changes
Other Study ID Numbers: C-011
Study First Received: October 15, 2008
Last Updated: October 15, 2008
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013