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
18 Years
N/A
Both
Lymphoma, Large B-Cell, Diffuse
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response
Outcome Description:
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.
Outcome Time Frame:
Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan
Safety Issue:
No
Authority:
Korea: Institutional Review Board
Study ID:
CISL-2007
NCT ID:
NCT01157988
Start Date:
January 2007
Completion Date:
Related Keywords:
- Lymphoma, Large B-Cell, Diffuse
- bulky diffuse large B cell lymphoma
- 90Y-ibritumomab tiuxetan
- clinical response
- Safety and toxicity
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
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