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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-08192 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10388 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This phase II trial studies how well nivolumab works for the treatment of hematological malignancies that have come back (relapsed), does not respond (refractory), or is detectable after CAR T cell therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (nivolumab) | Experimental | Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate (ORR) | Assessed by disease-specific guidelines: multiple myeloma - International Myeloma Working Group response criteria, non-Hodgkin lymphoma - Response assessment will be based on the Lugano Criteria, and chronic lymphocytic leukemia - Response assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria. ORR will be estimated, and its corresponding 95% exact binomial confidence interval (CI) will be provided. | Up to 1 year and 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Will employ Kaplan-Meier and Cox proportional hazard model methodology. | From the first study drug administration to death from any cause, up to 5 years |
| Progression-free Survival |
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Inclusion Criteria:
Diagnosis of the following tumor types
Non Hodgkin-lymphoma, including:
Chronic lymphocytic leukemia: Histopathologic or flow cytometric confirmation
Multiple myeloma: Histopathologic or flow confirmation
Relapsed, refractory, or detectable disease after treatment with chimeric antigen receptor T-cells
* Multiple Myeloma: patients must have exhausted all treatment options known to provide clinical benefit, and are refractory to a minimum of 3 prior lines of therapy (including an immunomodulatory imide drug [IMiD], proteasome inhibitor [PI], or anti-CD38 monoclonal antibody)
Have measurable disease, defined by histology:
Non-Hodgkin's lymphoma, based on presence of lesions >= 1.5 cm that can be accurately measured in 2 dimensions by computed tomography (CT) (preferred) or magnetic resonance imaging (MRI), and are not included in any prior field of radiation therapy
Chronic lymphocytic leukemia: circulating lymphocytes >= 5,000 / mm^3
Multiple myeloma, based on the International Myeloma Working Group (IMWG) criteria of having one or more of the following findings:
Age 18 years and older, and have the capacity to give informed consent
Anticipated survival of > 3 months
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Post CAR T cell receipt of intervening palliative radiation therapy is allowed
Estimated glomerular filtration rate (eGFR) >= 20 ml/min
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
Total bilirubin =< 2 x ULN
Absolute neutrophil count (ANC) >= 1,000/uL
Platelets >= 50,000/uL
Hemoglobin >= 8 g/dL
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rahul Banerjee, MD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Nivolumab) | Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2023 |
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Will employ Kaplan-Meier and Cox proportional hazard model methodology.
| From first study drug administration to the first occurrence of disease progression or death from any cause, up to 1 year and 8 months |
| Duration of Response | Will employ Kaplan-Meier and Cox proportional hazard model methodology. | Up to 1 year and 7 months |
| Incidence of Adverse Events | Will be determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Safety data will be summarized descriptively. Adverse events will be summarized by severity, seriousness, and relationship to study drug. | Up to 30 days after the last dose of study drug, up to a maximum of 1 year and 9 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Nivolumab) | Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Best Overall Response Rate (ORR) | Assessed by disease-specific guidelines: multiple myeloma - International Myeloma Working Group response criteria, non-Hodgkin lymphoma - Response assessment will be based on the Lugano Criteria, and chronic lymphocytic leukemia - Response assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria. ORR will be estimated, and its corresponding 95% exact binomial confidence interval (CI) will be provided. | Posted | Count of Participants | Participants | Up to 1 year and 8 months |
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| Secondary | Overall Survival | Will employ Kaplan-Meier and Cox proportional hazard model methodology. | Posted | Count of Participants | Participants | From the first study drug administration to death from any cause, up to 5 years |
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| Secondary | Progression-free Survival | Will employ Kaplan-Meier and Cox proportional hazard model methodology. | Posted | Count of Participants | Participants | From first study drug administration to the first occurrence of disease progression or death from any cause, up to 1 year and 8 months |
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| Secondary | Duration of Response | Will employ Kaplan-Meier and Cox proportional hazard model methodology. | Posted | Median | Full Range | months | Up to 1 year and 7 months |
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| Secondary | Incidence of Adverse Events | Will be determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Safety data will be summarized descriptively. Adverse events will be summarized by severity, seriousness, and relationship to study drug. | Posted | Count of Participants | Participants | Up to 30 days after the last dose of study drug, up to a maximum of 1 year and 9 months |
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Adverse events are collected from time of consent through 30 days after last dose of study drug, up to a maximum of 1 year 9 months. Deaths were assessed for up to 5 years.
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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 | Treatment (Nivolumab) | Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV | 13 | 20 | 10 | 20 | 18 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation with RVR | Cardiac disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Disease progression | General disorders | Systematic Assessment |
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| Febrile neutropenia | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Pneumonitis | Infections and infestations | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Body aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fecal incontinence | Gastrointestinal disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Flu like symptoms | General disorders | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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| Gas | Gastrointestinal disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fragility | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Peripheral neuropathy | Nervous system disorders | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural infection | Infections and infestations | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Respiratory depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Small intestinal bacterial overgrowth | Gastrointestinal disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Steatorrhea | Gastrointestinal disorders | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Watering eyes | Eye disorders | Systematic Assessment |
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| White blood cell decreased | Investigations | Systematic Assessment |
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| Jaw pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vision decreased | Eye disorders | Systematic Assessment |
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| Pharyngeal congestoin | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Cowan | University of Washington | 2066067348 | ajcowan@fredhutch.org |
| Sep 9, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2021 | Feb 3, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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