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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan
Korea: Institutional Review Board