Status:
COMPLETED
90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma
Lead Sponsor:
Chonnam National University Hospital
Collaborating Sponsors:
Samsung Medical Center
Asan Medical Center
Conditions:
Lymphoma, Large B-Cell, Diffuse
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lar...
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 compa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01157988
Start Date
January 1 2007
Last Update
July 8 2010
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea, 519-809