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slow accrual
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| Name | Class |
|---|---|
| Tibotec Pharmaceutical Limited | INDUSTRY |
Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma (NHL). The study will examine the tolerability and feasibility to the combination of Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab.
Elderly NHL patients tend to tolerate the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) less well when compared to the younger population. Cardiotoxicity, as well as neutropenia, are the most common side effects in the elderly population with age being a risk factor for doxorubicin induced cardiac toxicity. Treatment related toxicity in the older population can preclude adequate therapy and potentially contribute to poor outcomes. Pegylated liposomal doxorubicin has shown similar efficacy with a significant lower incidence of cardiotoxicity ad significantly fewer cardiac events compared with conventional doxorubicin. Exploration of alternative regimens to maximize tolerability and thus enhance overall efficacy in this population is warranted. Both safety and efficacy will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDOP plus rituximab | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | ||
| duration of response | ||
| median time to disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lodovico Balducci, MD | Geriatric Oncology Consortium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxnard | California | 93030 | United States | |||
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| overall survival |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Inverness | Florida | 34452 | United States |
| Lecanto | Florida | 34461 | United States |
| Belleville | New Jersey | 07109 | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| 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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