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To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inotuzumab Ozogamicin (CMC-544) | Drug | Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas). | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20491780 | Derived | Ogura M, Tobinai K, Hatake K, Uchida T, Kasai M, Oyama T, Suzuki T, Kobayashi Y, Watanabe T, Azuma T, Mori M, Terui Y, Yokoyama M, Mishima Y, Takahashi S, Ono C, Ohata J. Phase I study of inotuzumab ozogamicin (CMC-544) in Japanese patients with follicular lymphoma pretreated with rituximab-based therapy. Cancer Sci. 2010 Aug;101(8):1840-5. doi: 10.1111/j.1349-7006.2010.01601.x. Epub 2010 Apr 23. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
|---|---|
| D000080045 | Inotuzumab Ozogamicin |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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