Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
Information provided by:
Cooperative Study Group A for Hematology Identifier:
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

Condition Intervention Phase
Acute Lymphoblastic Leukemia
Phase 2

Study Type: Interventional
Study Design: 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 ]

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

Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00774332

Contact: Jung-Hee Lee, doctor 82-2-3010-5794

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

Responsible Party: Yeungnam University College of Medicine Identifier: NCT00774332     History of Changes
Other Study ID Numbers: C-011
Study First Received: October 15, 2008
Last Updated: October 15, 2008

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on May 24, 2017