90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chonnam National University Hospital
• Collaborators: Asan Medical Center; Chonbuk National University Hospital; Dong-A University Hospital; Pusan National University Hospital; Samsung Medical Center; Severance Hospital
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Newly diagnosed CD20+ DLBCL

• Patients with stage I/II

• Bulky disease defined by maximum diameter greater than 10 cm or any mediastinal mass exceeding 1/3 the maximum trans- thoracic diameter (more than 8 cm)

• Patients that achieved a complete (CR) or partial response (PR) after 6th R-CHOP chemotherapy

• Aged over 18 years

• ECOG performance status 0-2.

Exclusion Criteria:

• Previous history of chemotherapy for diffuse large B cell lymphoma

• Prior myeloablative therapy

• Prior external-beam radiation to >25% of active bone marrow

• Pregnancy and lactation

• >25% bone marrow infiltration

• Platelet counts <100 000/µl, neutrophil counts <1500/µl

• Children and adolescents under 18 years of age

• Presence of CNS involvement with diffuse large B cell lymphoma

• Positive HIV serology

• Seriously uncontrolled, current infections or other concomitant