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

Cooperative Study Group A for Hematology

Status and phase: Unknown; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: CODOX-M

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00774332

C-011

Details and patient eligibility

About

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

Full description

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

Enrollment: 37 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)