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

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ClinicalTrials.gov Identifier: NCT00774332
Recruitment Status : Unknown
Verified October 2008 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
First Posted : October 17, 2008
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology

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

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: CODOX-M Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
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
Study Start Date : June 2006
Primary Completion Date : June 2006
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: CODOX-M
    Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine


Primary Outcome Measures :
  1. Duration of complete remission, disease-free survival, overall survival, toxicities [ Time Frame: 2009 ]


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.

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

Responsible Party: Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT00774332     History of Changes
Other Study ID Numbers: C-011
First Posted: October 17, 2008    Key Record Dates
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