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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01707 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2014-0123 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well a dose adjusted regimen consisting of etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH) works in combination with ofatumumab or rituximab in treating patients with Burkitt lymphoma that is newly diagnosed, or has returned after a period of improvement (relapsed), or has not responded to previous treatment (refractory) or relapsed or refractory acute lymphoblastic leukemia. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ofatumumab and rituximab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) together with monoclonal antibody therapy may kill more cancer cells.
PRIMARY OBJECTIVE:
I. To evaluate the clinical efficacy of the combination of dose adjusted (DA)-EPOCH + ofatumumab in patients with newly diagnosed or relapsed/refractory Burkitt leukemia or relapsed/refractory acute lymphoblastic leukemia (ALL) defined by complete response rate.
SECONDARY OBJECTIVE:
I. To evaluate the safety of this combination, the overall survival and event-free survival rates.
OUTLINE:
Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride intravenously (IV), vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone orally (PO) twice daily (BID) on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2-4 months for 1 year and then every 4-8 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (DA-EPOCH and ofatumumab or rituximab) | Experimental | Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With a Response | Complete Remission: Normalization of the peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 109/L or above and platelet count of 100 x 10^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR. | Up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Time | Time from date of treatment start until date of death due to any cause or last Follow-up. | Up to 8 years |
| Event-free Survival | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elias Jabbour, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (DA-EPOCH and Ofatumumab or Rituximab) | Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: 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 14, 2019 |
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| Doxorubicin Hydrochloride | Drug | Given IV |
|
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| Etoposide | Drug | Given IV |
|
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| Ofatumumab | Biological | Given IV |
|
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| Prednisone | Drug | Given PO |
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| Rituximab | Biological | Given IV |
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| Vincristine Sulfate | Drug | Given IV |
|
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| Up to 8 years |
| Complete Response Duration | Response date to loss of response or last follow up. | Up to 8 years |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (DA-EPOCH and Ofatumumab or Rituximab) | Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: 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 |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | 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 | Participants With a Response | Complete Remission: Normalization of the peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 109/L or above and platelet count of 100 x 10^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR. | Posted | Count of Participants | Participants | Up to 8 years |
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| Secondary | Overall Survival Time | Time from date of treatment start until date of death due to any cause or last Follow-up. | Posted | Median | Full Range | Months | Up to 8 years |
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| Secondary | Event-free Survival | Time from date of treatment start until the date of first objective documentation of disease-relapse. | Posted | Median | Full Range | Months | Up to 8 years |
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| Secondary | Complete Response Duration | Response date to loss of response or last follow up. | Posted | Median | Full Range | Months | Up to 8 years |
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Up to 8 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 (DA-EPOCH and Ofatumumab or Rituximab) | Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV | 0 | 14 | 4 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter Related Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Septic Shock | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Back pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Bilirubin increase | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Fall (Bone Pain) | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increase | Investigations | CTCAE (4.0) | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| dyspnea | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema (legs) | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema, limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Genital Edema | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| hemorrhoid | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Leg cramps | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil count decrease | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decrease | Investigations | CTCAE (4.0) | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| White blood cell count decrease | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elias Joseph Jabbour | The University of Texas MD Andeerson Cancer Center | 713-792-4764 | ejabbout@mdanderson.org |
| Feb 6, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| 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 |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| C527517 | ofatumumab |
| D011241 | Prednisone |
| C407664 | deltacortene |
| C036266 | prednylidene |
| D000069283 | Rituximab |
| C000626854 | CT-P10 |
| D014750 | Vincristine |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring 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 |
| 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 |
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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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