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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Asan Medical Center | OTHER |
| Chonbuk National University Hospital | OTHER |
| Dong-A University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibritumomab tuixetan, response, toxicity | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibritumomab tiuxetan (Zevalin) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response | 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 |
| Safety and toxicity | 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. | 3 years after the infusion of 90Y-ibritumomab tiuxetan |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | the time from start of R-CHOP to the first recording of disease progression or death of any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Hwasun-gun | Jeollanam-do | 519-809 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22035417 | Derived | Yang DH, Kim WS, Kim SJ, Kim JS, Kwak JY, Chung JS, Oh SY, Suh C, Lee JJ. Pilot trial of yttrium-90 ibritumomab tiuxetan consolidation following rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone chemotherapy in patients with limited-stage, bulky diffuse large B-cell lymphoma. Leuk Lymphoma. 2012 May;53(5):807-11. doi: 10.3109/10428194.2011.635857. Epub 2011 Dec 7. |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C422802 | ibritumomab tiuxetan |
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| OTHER |
| Pusan National University Hospital | OTHER |
| Severance Hospital | OTHER |
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |