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| Name | Class |
|---|---|
| Ortho Biotech Products, L.P. | INDUSTRY |
The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.
Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma with more than half of the patients being over the age of 60 years. Elderly patients with cancer are defined by the American Society of Clinical Oncology as a "special population" due to their disease characteristics, additional health problems, and need for aggressive supportive care strategies to reduce morbidity and mortality. The combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) remains as standard therapy for the treatment of DLBCL, but elderly patients tend to tolerate the CHOP therapy less when compared to younger patients. Cardiac toxicity, as well as decrease in blood counts, are the most common side effects in the elderly population. For these reasons, many doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly for fear of increased morbidity. DLBCL in the elderly is also somewhat unique in that the elderly patients appear to have more aggressive disease and poor overall outcome. In order to maximize the tolerability of treatment and thus potentially enhance overall treatment success in this population, it is necessary to look at alternative treatments. This clinical trial is based on currently accepted standard NHL therapy (CHOP-Rituximab) in which Doxil is substituted for Adriamycin. Growth factor will be used for support of acceptable blood counts. Chemotherapy regimens that include rituximab are now the gold standard for treatment of DLBCL. If indeed, delivering full dose chemotherapy without treatment delays leads to higher remission and cure rates, then this offers a significant proportion of NHL patients who are elderly a chance for cure rather than providing treatment for comfort measures while preserving quality of life.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxil | Drug | |||
| Cyclophosphamide | Drug | |||
| Vincristine | Drug | |||
| Prednisone | Drug | |||
| Rituximab | Drug | |||
| Pegfilgrastim | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0 | ||
| Efficacy: tumor evaluations every three (q 3) cycles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pam Nickoles, RN, BSN | Contact | 410-601-0729 | pnickole@lifebridgehealth.org | |
| Judy Bosley, RN, BSN | Contact | 410-601-4392 | jbosley@lifebridgehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Noga, MD, PhD | Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinai Hospital of Baltimore | Recruiting | Baltimore | Maryland | 21215 | United States |
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| Northwest Hospital Center | Recruiting | Randallstown | Maryland | 21133 | United States |
|
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| 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 |
|---|---|
| C506643 | liposomal doxorubicin |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D000069283 | Rituximab |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| 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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