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

Phase 2

Completed

• Conditions: Lymphoma, Large B-Cell, Diffuse
• Interventions: Drug: ibritumomab tiuxetan (Zevalin)

• Registration Number: NCT01157988
• Lead Sponsor: Chonnam National University Hospital

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2006-04
• Study Start: 2007-01
• Primary Completion: 2009-01
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-07
• Last Update Submitted: 2010-07-07
• Study First Posted: 2010-07-08
• Last Update Posted: 2010-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ibritumomab tuixetan, response, toxicity	ibritumomab tiuxetan (Zevalin)	-

Primary Outcome Measures

Name	Time	Method
Objective response	Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan	Patients receive six cycles of R-CHOP chemotherapy per 21-day intervals. Patients with clearly documented progressive disease will be taken off the study when progression is noted. Patients who achieved a complete or partial response after 6th R-CHOP chemotherapy will receive ibritumomab tiuxetan treatment as a consolidation.
Safety and toxicity	3 years after the infusion of 90Y-ibritumomab tiuxetan	After Zevalin treatment, safety profiles will be evaluated with physical examination, vital signs, performance status, serum chemistry and electrolytes, and lymphocytes subset using NCI Common Terminology Criteria for Adverse Events version 3.0, every 4 weeks for 6 months, and then every 3 months for the next 6 months.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	the time from start of R-CHOP to the first recording of disease progression or death of any cause

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun-gun, Jeollanam-do, Korea, Republic of