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| Name | Class |
|---|---|
| Ortho Biotech, Inc. | INDUSTRY |
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The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DR-COP | Experimental | On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone | Drug | Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) Prednisone 100 mg po days 1-5
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complete Response to the Combination Chemotherapy | Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study. Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas" by Cheson et al (23). | At completion of cycle 4, 6, and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability | Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom. | At end of every cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Tulpule, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033 | United States |
There were no pre-assignment criteria. All subjects were given the same treatment.
The study began recruiting in January 2003 and ended in December 2007. All subjects were seen and treated either at USC Norris Comprehensive Cancer Center or at LAC+USC Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | DR-COP | On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DR-COP | On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Complete Response to the Combination Chemotherapy | Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study. Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas" by Cheson et al (23). | Posted | Number | Percentage of participants | At completion of cycle 4, 6, and 8 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability | Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom. | Posted | Count of Participants | Participants | At end of every cycle |
|
|
Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DR-COP | On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 | 3 | 68 | 35 | 68 | 27 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac left ventricular function | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac troponin I (cTnl) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea patients without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment | Fever of unknown origin without clinically or microbiologically documented infection (ANC <1.0 x 10e9/L, fever >= 38.5 degrees C) |
|
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ileus (or neuroconstipation) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment | Documented clinically or microbiologically with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L) |
|
| Infection without neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Melena/GI bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia (muscle pain) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis/pharingitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ureteral obstruction | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alkalosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ascites (non-malignant) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac left ventricular function | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Chest pain (non-cardiac and non-pleuritic) | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea patients without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysuria (painful urination) | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment | In the absence of neutropenia, where neutropenia is defined as AGC <1.0 x 10e9/L |
|
| Flatulence | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage/bleeding | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment | Without grade 3 or 4 thrombocytopenia |
|
| Hot flashes/flushes | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ileus (or neuroconstipation) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Melena/GI bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mood alteration-anxiety, agitation | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mood alteration-depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mouth dryness | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia (muscle pain) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy-motor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain due to radiation | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pigmentation changes (e.g., vitiligo) | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pleural Effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rigors, chills | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sense of smell | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Skin-Laate RT Morbidity Scoring | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sweating (eiaphoresis) | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Taste disturbance (dysgeusia) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Wound-infectious | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Soto - Project Specialist | USC Norris Comprehensive Cancer Center | (323) 865-0454 | Victoria.Soto@med.usc.edu |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| 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 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|