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

Chonnam National University

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Large B-Cell, Diffuse

Treatments: Drug: ibritumomab tiuxetan (Zevalin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01157988

CISL-2007

Details and patient eligibility

About

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).

Full description

The patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL) are known to have a poor prognosis as like to those with advanced disease. However, there are very limited studies to compare the clinical outcome of therapy after chemotherapy only with combined modality using radiation. Defining local failure at bulky sites as one component of relapse, radioimmuotherapy appears to reduce the failure rates at previous bulky sites. We assessed the clinical efficacy and toxicity of 6th R-CHOP chemotherapy and followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky DLBCL.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ibritumomab tuixetan, response, toxicity

Experimental group

Treatment:

Drug: ibritumomab tiuxetan (Zevalin)