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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 27, 2014