Trial | NCT01157988  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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).
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 Started
Jan 31
2007
Primary Completion
Jan 31
2009
Last Update
Jul 08
2010
Estimate

Drug ibritumomab tiuxetan (Zevalin)

During Zevalin treatment, rituximab 250 mg/m2 will be administered with the same methods mentioned above on days 1 and 8. On day 8, within 4 hours following completion of the rituximab dose, 90Y Zevalin at a dose of 0.4 mCi/kg actual body weight for patients with a platelet count > 150,000/L and 0.3 mCi/kg actual body weight for patients with a platelet count of 100,000 - 149,000/L will be injected intravenously over a period of 10 minutes. The maximum allowable dose of 90Y Zevalin is 32 mCi regardless of the patient's body weight. 90Y Zevalin should be administered within 4 hours after radiolabeling of Zevalin with 90Y.

ibritumomab tuixetan, response, toxicity Experimental

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
No Results Posted