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| ID | Type | Description | Link |
|---|---|---|---|
| 305618 |
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The purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zevalin (SH L 749 , BAY86-5128) | Drug | 0,3mCi/kg |
| |
| Zevalin (SH L 749 , BAY86-5128) |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response rates (the percentage of patients who achieved PR or better response) | After 9 weeks or 13 weeks | |
| The incidence of critical toxicity | During treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | During treatment period | |
| Complete response (CR or CRu) rates | After 9 weeks or 13 weeks | |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 464-8681 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19018755 | Derived | Tobinai K, Watanabe T, Ogura M, Morishima Y, Hotta T, Ishizawa K, Itoh K, Okamoto S, Taniwaki M, Tsukamoto N, Okumura H, Terauchi T, Nawano S, Matsusako M, Matsuno Y, Nakamura S, Mori S, Ohashi Y, Hayashi M, Endo K. Japanese phase II study of 90Y-ibritumomab tiuxetan in patients with relapsed or refractory indolent B-cell lymphoma. Cancer Sci. 2009 Jan;100(1):158-64. doi: 10.1111/j.1349-7006.2008.00999.x. Epub 2008 Oct 24. |
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| Drug |
0,4mCi/kg |
|
| After end of study |
| Kashiwa-shi |
| Chiba |
| 277-8577 |
| Japan |
| Maebashi | Gunma | 371-8511 | Japan |
| Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Isehara-shi | Kanagawa | 259-1193 | Japan |
| Kyoto | Kyoto | 602-0841 | Japan |
| Sendai | Miyagi | 980-0872 | Japan |
| Chuo-ku | Tokyo | 104-0045 | Japan |
| Shinjuku-ku | Tokyo | 160-8582 | Japan |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C422802 | ibritumomab tiuxetan |
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