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

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 October 2008 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00774332
First Posted: October 17, 2008
Last Update Posted: October 17, 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
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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT00774332     History of Changes
Other Study ID Numbers: C-011
First Submitted: October 15, 2008
First Posted: October 17, 2008
Last Update Posted: October 17, 2008
Last Verified: October 2008

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