Phase II Study of 90Y-ibritumomab Tiuxetan Treatment as a Consolidation After 6th R-CHOP Chemotherapy in Patients With Limited-stage, Bulky Diffuse Large B Cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- ibritumomab tiuxetan (Zevalin)
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Sponsor
- Chonnam National University Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Objective response
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
ibritumomab tuixetan, response, toxicity
Intervention: ibritumomab tiuxetan (Zevalin)
Outcomes
Primary Outcomes
Objective response
Time Frame: 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
Time Frame: 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 Outcomes
- Progression-free survival(the time from start of R-CHOP to the first recording of disease progression or death of any cause)