90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01157988|
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : July 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Large B-Cell, Diffuse||Drug: ibritumomab tiuxetan (Zevalin)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2009|
|Experimental: ibritumomab tuixetan, response, toxicity||
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.
- 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.
- Progression-free survival [ Time Frame: the time from start of R-CHOP to the first recording of disease progression or death of any cause ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157988
|Korea, Republic of|
|Chonnam National University Hwasun Hospital|
|Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809|