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

• Sponsor: Cooperative Study Group A for Hematology (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00774332
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 37 participants
• Allocation: N/A
• 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: Jun 1, 2006
• Actual Primary Completion Date: Jun 1, 2006
• Anticipated Study Completion Date: Dec 1, 2009

Outcome Measures

Primary Outcome Measures

1. Duration of complete remission, disease-free survival, overall survival, toxicities [2009]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 65 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Cooperative Study Group A for Hematology

Investigators

• Principal Investigator: Jung-Hee Lee, Doctor, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00774332
• Other Study ID Numbers: C-011
• First Posted: Oct 17, 2008
• Last Update Posted: Oct 17, 2008
• Last Verified: Oct 1, 2008

• Additional relevant MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Oct 17, 2008