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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00774332
• Other study ID #: C-011
• Status: Recruiting
• Phase: Phase 2
• First received: October 15, 2008
• Last updated: October 15, 2008
• Start date: June 2006
• Est. completion date: December 2009

Study information

• Verified date: October 2008
• Source: Cooperative Study Group A for Hematology
• Contact: Jung-Hee Lee, doctor
• Phone: 82-2-3010-5794
• Email: jhleecr[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: December 2009
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of complete remission, disease-free survival, overall survival, toxicities		2009	Yes