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| ID | Type | Description | Link |
|---|---|---|---|
| 16-C-0171 |
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Background:
Primary effusion lymphoma (PEL) is a rare disease with no standard treatment. Researchers want to see if a drug called lenalidomide along with common chemotherapy drugs may be effective in treating PEL.
Objective:
To test a new treatment for PEL.
Eligibility:
People ages 18 and older with PEL.
Design:
Participants will be screened with blood tests, imaging studies, a physical exam, and other tests.
Participants will have tests to evaluate their disease. These may include:
Blood tests
Scans
Lumbar puncture. Fluid around the spinal cord will be removed with a needle.
Bone marrow removed with a needle and studied
Samples of skin or lymph nodes removed
Fluid removed from around organs
Lung and eye tests
Tubes with cameras taking pictures of airways or digestive tract
Participants will take lenalidomide pills for 10 days. They will keep a pill diary.
Participants will have a catheter (small tube) placed in the large vein in the arm or chest.
Participants will get DA-EPOCH-R as intravenous infusions by catheter over several days. This will be repeated in 21-day cycles. Most participants will have 6 cycles.
Participants will get the drug filgrastim by injection under the skin. They will get the drug methotrexate injected into the spinal fluid.
During the study, participants will have the following tests done at least once:
Medical history
Physical exam
Blood, urine, and stool tests
Lesions photographed and measured
Lumbar puncture
Participants will have follow-up visits for 5 years. They will repeat the screening tests plus have urine and stool tested.
Participants may be contacted later by phone to see how they are doing.
Background
Objectives
Phase I
- Evaluate safety and tolerability of lenalidomide in combination with DA-EPOCH-R and determine the maximum tolerated dose and/or recommended phase II dose of this regimen.
Phase II
- Evaluate overall survival in treatment-naive participants with KSHV-positive aggressive B cell lymphomas treated with lenalidomide in combination with DA-EPOCH and rituximab (DA-EPOCH-R^2).
Eligibility
Design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide, Rituximab, Prednisone, Etoposide, Doxorubicin, Vincristine and Cyclophosphamide | Experimental | Lenalidomide, Rituximab, Prednisone, Etoposide, Doxorubicin, Vincristine and Cyclophosphamide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide taken orally, daily at assigned dose level on days 1 to 10, up to 25mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| (Phase I) Maximum Tolerated Dose (MTD) of Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) | The MTD is the dose level at which no more than 1 of up to 6 participants experiences dose-limiting toxicity (DLT) during the first two cycles of DA-EPOCH-R2 treatment. Association of treatment regimen with one-year overall survival. DLT is defined as any grade 4 adverse event at least possibly related to lenalidomide and not probably or definitely related to human immunodeficiency virus (HIV) or a Kaposi sarcoma-associated herpesvirus KSHV-associated malignancy resulting in a dose delay in etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) treatment >2 weeks due to failure to resolve to grade 3 or lower. Any grade 3 cardiac toxicity that is at least possibly related to lenalidomide and not probably or definitely related to HIV or a Kaposi sarcoma-associated herpesvirus (KSHV)-associated malignancy resulting in a dose delay in DA-EPOCH-R treatment >2 weeks due to failure to resolve to grade 2 or lower. | First 6 weeks of treatment (2 cycles of treatment) |
| (Phase II) Overall Survival in Treatment-naive Participants With Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 90% Confidence Interval | Median amount of time subject survives post therapy | End of follow up period (5 years) |
| (Phase II) Overall Survival in Treatment-naive Participants With Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 95% Confidence Interval | Median amount of time subject survives post therapy. | End of follow up period (5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate for Primary Effusion Lymphoma Reported Using a 90% Confidence Interval | Response rate is defined as the percentage of participants who have either a complete response (CR) or partial response (PR) for primary effusion lymphoma treated with etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R2) measured by the International Working Group Response Criteria for Malignant Lymphomas. Complete response (CR) is complete disappearance of all detectable evidence of disease. Partial response (PR) is at least a ≥50% decrease in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Dose-limiting Toxicity (DLT) | DLT's as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). DLT is defined as any grade 4 adverse event at least possibly related to lenalidomide and not probably or definitely related to human immunodeficiency virus (HIV) or a Kaposi sarcoma-associated herpesvirus (KSHV)associated malignancy resulting in a dose delay in etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) treatment >2 weeks due to failure to resolve to grade 3 or lower. Any grade 3 cardiac toxicity that is at least possibly related to lenalidomide and not probably or definitely related to HIV or a KSHV-associated malignancy resulting in a dose delay in DA-EPOCH-R treatment >2 weeks due to failure to resolve to grade 2 or lower. DLT's were used to determine whether to stop or hold therapy in an individual participant as well as to expand individual dose levels from 3 to 6 participants. |
EXCLUSION CRITERIA:
Use of other systemic anticancer treatments or agents within the past 2 weeks. The use of rituximab for the treatment of KSHV-associated multicentric Castleman disease (MCD) or KSHV inflammatory cytokine syndrome (KICS) or the use of steroids are allowed within 2 weeks prior to start of treatment.
Phase I or Phase II participants who have received prior dose-adjusted EPOCH for treatment for PEL or KSHV-associated large cell lymphoma
Phase II participants who have received any prior curative-intent therapy for PEL or KSHV-associated large cell lymphoma. Participants who have received prior treatment as a bridge to curative-intent therapy will be considered per PI discretion.
Parenchymal brain involvement with lymphoma
History of malignant tumors other than KS or KSHV-associated MCD, unless:
Inadequate renal function, defined as calculated or estimated creatinine clearance < 60 mL/min unless lymphoma, KSHV-MCD, or KICS- related for calculation of creatinine clearance)
Inadequate hepatic function
Bilirubin (total) > 1.5 times the upper limit of normal; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal; EXCEPTIONS:
Absolute neutrophil count (ANC) <1000/mm^3 and platelets < 75,000/mm^3 unless lymphoma, KSHV-MCD, or KICS- related.
Common Terminology Criteria for Adverse Events (CTCAE)v5.0 Grade 3-4 neuropathy
Ejection fraction less than 40% by echocardiography
Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.
History of hypersensitivity reactions attributed to thalidomide, lenalidomide, or pomalidomide, including prior development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide, or pomalidomide.
Breast feeding (if lactating, must agree not to breast feed while taking lenalidomide). Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide.
Uncontrolled severe intercurrent illness including, but not limited to bacterial, fungal, or life-threatening viral infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements. Participants with severe intercurrent illnesses attributed to lymphoma, KSHV-MCD, or KICS may be eligible per principal investigators (PI's) or designees' discretion.
Any condition, including laboratory abnormalities, which in the opinion of the Principal Investigator or Lead Associate Investigator, would prohibit administration of planned chemotherapeutic intervention, places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study
Pregnant women are excluded from this study because lenalidomide is a Category X agent with the potential for teratogenic or abortifacient effects. These potential risks may also apply to other agents used in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Ramya Ramaswami, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Clinical data available during the study and indefinitely.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab | Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m^2/day, Vincristine 0.4 mg/m^2 /day, and Doxorubicin 10 mg /m^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase I - Safety & Tolerability |
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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 | Jun 6, 2023 |
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| Rituximab | Drug | During cycle 1, rituximab will be administered on day 4 prior to the start of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH). During cycles 2 to 6, rituximab will be administered on day 1 of each cycle. |
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| Prednisone | Drug | During cycle 1, Prednisone 60 mg/m^2 /day by mouth (PO) days 6 to 10. During cycles 2-6, Prednisone 60 mg/m^2 /day PO days 1-5. |
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| Etoposide | Drug | During cycle 1, Etoposide 50 mg/m^2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide 50 mg/m^2/day continuous intravenous infusion days 1 to 4. |
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| Doxorubicin | Drug | During cycle 1, Doxorubicin 10 mg /m^2/day continuous intravenous infusion days 6 to 9. During cycles 2-6, Doxorubicin continuous intravenous infusion days 1 to 4. |
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| Vincristine | Drug | During cycle 1, Vincristine 0.4 mg/m^2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Vincristine continuous intravenous infusion days 1 to 4. |
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| Cyclophosphamide | Drug | During cycle 1, Cyclophosphamide 750 mg/m^2 day 10. During cycles 2-6, Cyclophosphamide 750 mg/m^2 day 5. |
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| CT of neck, chest, abdomen and pelvis | Diagnostic Test | Screening |
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| 18FDG-PET scan | Diagnostic Test | Baseline |
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| MRI Brain | Diagnostic Test | Screening |
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| Bone marrow biopsy | Procedure | Baseline |
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| EKG | Diagnostic Test | Screening |
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| Echocardiogram | Diagnostic Test | Screening |
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| Ultrasound | Diagnostic Test | Day 6 |
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| Bronchoscopy | Diagnostic Test | Baseline |
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| Endoscopy | Diagnostic Test | Baseline |
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| CXR: PA/lat/decub | Diagnostic Test | Screening |
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| Response rate was calculated at the end of treatment (18 weeks of treatment) |
| Response Rate for Primary Effusion Lymphoma Reported Using a 95% Confidence Interval | Response rate is defined as the percentage of participants who have either a Complete Response (CR) or Partial Response (PR) for primary effusion lymphoma treated with etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R2) measured by the International Working Group Response Criteria for Malignant Lymphomas. Complete response (CR) is complete disappearance of all detectable evidence of disease. Partial response (PR) is at least a ≥50% decrease in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. | Response rate was calculated at the end of treatment (after 18 weeks of treatment) |
| Progression-free Survival (PFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Using a 90% Confidence Interval | PFS is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma or death, whichever occurs first, measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules). | Over follow-up period, a median of 26 months |
| Progression-free Survival (PFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Using a 95% Confidence Interval | PFS is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma or death, whichever occurs first, measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules). | Over a follow-up period, a median of 26 months |
| Event-free Survival (EFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 90% Confidence Interval | Event-Free Survival (EFS) is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma. Progressive disease was measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is the appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules). | Over a follow-up period, a median of 26 months |
| Event-free Survival (EFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 95% Confidence Interval | Event-Free Survival (EFS) is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma. Progressive disease was measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is the appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules). | Over a follow-up period, a median of 26 months |
| Response Assessment of Kaposi Sarcoma Using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria Reported Along With a 90% Confidence Interval | Response was assessed by the percentage of participants with either a partial or complete response. Response was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria. Complete Response is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. The absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. Partial Response is a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or no new lesions occurring in previously uninvolved areas of the body. | At end of treatment (after 18 weeks treatment) |
| Response Assessment of Kaposi Sarcoma Using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria Reported Along With a 95% Confidence Interval | Response was assessed by the percentage of participants with either a partial or complete response. Response was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria. Complete Response is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. The absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. Partial Response is a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or no new lesions occurring in previously uninvolved areas of the body. | At end of treatment (after 18 weeks of treatment) |
| Response Rate of Participants With Active Multicentric Castleman Disease (MCD) Assessed by the National Cancer Institute (NCI) MCD Response Criteria Reported Along With a 90% Confidence Interval | Response rate is calculated by the percentage of participants with either a partial or complete response. Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to Kaposi sarcoma-associated herpesvirus (KSHV)-MCD must improve by the minimum amounts specified to attain PR (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). | At end of treatment (after 18 weeks of treatment) |
| Response Rate of Participants With Active Multicentric Castleman Disease (MCD) Assessed by the National Cancer Institute (NCI) MCD Response Criteria Reported Along With a 95% Confidence Interval | Response rate is calculated by the percentage of participants with either a partial or complete response. Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to Kaposi sarcoma-associated herpesvirus (KSHV)-MCD must improve by the minimum amounts specified to attain PR (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). | At end of treatment (after 18 weeks of treatment) |
| Kaposi's Sarcoma-associated Herpesvirus (KSHV)-Associated Inflammatory Cytokine Syndrome (KICS) Reported Along With a 90% Confidence Interval | Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to KICS, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to KICS must improve by the minimum amounts (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). Progressive disease (PD) is at least two indicator abnormalities must deteriorate by the minimum amounts specified below to constitute PD (e.g., C-reactive protein increase by ≥50% of baseline (or the upper limit of normal, whichever is greater); Hemoglobin decrement 2g/dL not otherwise explained; and Platelet decrement ≥25,000/mm^3 not otherwise explained). Stable disease (SD) is no change in signs and symptoms of KICS that meet criteria for any of CR, PR or PD. | At the end of treatment (after 18 weeks of treatment) |
| Kaposi's Sarcoma-associated Herpesvirus (KSHV)-Associated Inflammatory Cytokine Syndrome (KICS) Reported Along With a 95% Confidence Interval | Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to KICS, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to KICS must improve by the minimum amounts (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). Progressive disease (PD) is at least two indicator abnormalities must deteriorate by the minimum amounts specified below to constitute PD (e.g., C-reactive protein increase by ≥50% of baseline (or the upper limit of normal, whichever is greater); Hemoglobin decrement 2g/dL not otherwise explained; and Platelet decrement ≥25,000/mm^3 not otherwise explained). Stable disease (SD) is no change in signs and symptoms of KICS that meet criteria for any of CR, PR or PD. | At the end of treatment (after 18 weeks of treatment) |
| Pharmacokinetics of Lenalidomide in Blood | Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in blood using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program. | Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days) |
| Pharmacokinetics of Lenalidomide Effusion | Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in effusions using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program. | Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days) |
| Pharmacokinetics of Lenalidomide in Cerebrospinal Fluid (CSF) | Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in CSF using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program. | Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days) |
| First 6 weeks (2 cycles) of treatment |
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Median follow-up time was 26 months |
| Received Specified Dose |
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| Underwent Screening/Staging |
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| Evaluated for Response |
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| Off Treatment |
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| Off Study |
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| Disease Progression on Study |
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| COMPLETED |
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| NOT COMPLETED |
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| Phase II - Recommended Phase 2 Dose |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab | Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m^2/day, Vincristine 0.4 mg/m^2 /day, and Doxorubicin 10 mg /m^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | 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 | ||||||||||||||||||||
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| Primary | (Phase I) Maximum Tolerated Dose (MTD) of Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) | The MTD is the dose level at which no more than 1 of up to 6 participants experiences dose-limiting toxicity (DLT) during the first two cycles of DA-EPOCH-R2 treatment. Association of treatment regimen with one-year overall survival. DLT is defined as any grade 4 adverse event at least possibly related to lenalidomide and not probably or definitely related to human immunodeficiency virus (HIV) or a Kaposi sarcoma-associated herpesvirus KSHV-associated malignancy resulting in a dose delay in etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) treatment >2 weeks due to failure to resolve to grade 3 or lower. Any grade 3 cardiac toxicity that is at least possibly related to lenalidomide and not probably or definitely related to HIV or a Kaposi sarcoma-associated herpesvirus (KSHV)-associated malignancy resulting in a dose delay in DA-EPOCH-R treatment >2 weeks due to failure to resolve to grade 2 or lower. | 6/17 participants were analyzed because MTD was only assessed during phase I which was only 6 participants. | Posted | Number | mg/day | First 6 weeks of treatment (2 cycles of treatment) |
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| Primary | (Phase II) Overall Survival in Treatment-naive Participants With Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 90% Confidence Interval | Median amount of time subject survives post therapy | Posted | Median | 90% Confidence Interval | years | End of follow up period (5 years) |
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| Primary | (Phase II) Overall Survival in Treatment-naive Participants With Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 95% Confidence Interval | Median amount of time subject survives post therapy. | Posted | Median | 95% Confidence Interval | years | End of follow up period (5 years) |
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| Secondary | Response Rate for Primary Effusion Lymphoma Reported Using a 90% Confidence Interval | Response rate is defined as the percentage of participants who have either a complete response (CR) or partial response (PR) for primary effusion lymphoma treated with etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R2) measured by the International Working Group Response Criteria for Malignant Lymphomas. Complete response (CR) is complete disappearance of all detectable evidence of disease. Partial response (PR) is at least a ≥50% decrease in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. | Posted | Number | 90% Confidence Interval | percentage of participants | Response rate was calculated at the end of treatment (18 weeks of treatment) |
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| Secondary | Response Rate for Primary Effusion Lymphoma Reported Using a 95% Confidence Interval | Response rate is defined as the percentage of participants who have either a Complete Response (CR) or Partial Response (PR) for primary effusion lymphoma treated with etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R2) measured by the International Working Group Response Criteria for Malignant Lymphomas. Complete response (CR) is complete disappearance of all detectable evidence of disease. Partial response (PR) is at least a ≥50% decrease in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. | Posted | Number | 95% Confidence Interval | percentage of participants | Response rate was calculated at the end of treatment (after 18 weeks of treatment) |
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| Secondary | Progression-free Survival (PFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Using a 90% Confidence Interval | PFS is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma or death, whichever occurs first, measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules). | Posted | Median | 90% Confidence Interval | years | Over follow-up period, a median of 26 months |
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| Secondary | Progression-free Survival (PFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Using a 95% Confidence Interval | PFS is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma or death, whichever occurs first, measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules). | Posted | Median | 95% Confidence Interval | years | Over a follow-up period, a median of 26 months |
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| Secondary | Event-free Survival (EFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 90% Confidence Interval | Event-Free Survival (EFS) is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma. Progressive disease was measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is the appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules). | Posted | Median | 90% Confidence Interval | years | Over a follow-up period, a median of 26 months |
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| Secondary | Event-free Survival (EFS) for Primary Effusion Lymphoma Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) Reported Along With a 95% Confidence Interval | Event-Free Survival (EFS) is defined as the duration of time from start of treatment to time of progression of Kaposi sarcoma-associated herpesvirus (KSHV)-lymphoma. Progressive disease was measured by the International Working Group Response Criteria for Malignant Lymphoma. Progressive disease is the appearance of any new nodal lesion ≥1.6 cm in greatest transverse diameter (GTD) or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. At least a 50% increase from the nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or in the size of other lesions (e.g., splenic or hepatic nodules). | Posted | Median | 95% Confidence Interval | Months | Over a follow-up period, a median of 26 months |
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| Secondary | Response Assessment of Kaposi Sarcoma Using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria Reported Along With a 90% Confidence Interval | Response was assessed by the percentage of participants with either a partial or complete response. Response was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria. Complete Response is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. The absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. Partial Response is a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or no new lesions occurring in previously uninvolved areas of the body. | 4/17 participants were analyzed because only 4 participants had evaluable Kaposi sarcoma. | Posted | Number | 90% Confidence Interval | percentage of participants | At end of treatment (after 18 weeks treatment) |
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| Secondary | Response Assessment of Kaposi Sarcoma Using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria Reported Along With a 95% Confidence Interval | Response was assessed by the percentage of participants with either a partial or complete response. Response was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Criteria. Complete Response is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. The absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks. Partial Response is a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or no new lesions occurring in previously uninvolved areas of the body. | 4/17 participants were analyzed because only 4 participants had evaluable Kaposi sarcoma. | Posted | Number | 95% Confidence Interval | percentage of participants | At end of treatment (after 18 weeks of treatment) |
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| Secondary | Response Rate of Participants With Active Multicentric Castleman Disease (MCD) Assessed by the National Cancer Institute (NCI) MCD Response Criteria Reported Along With a 90% Confidence Interval | Response rate is calculated by the percentage of participants with either a partial or complete response. Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to Kaposi sarcoma-associated herpesvirus (KSHV)-MCD must improve by the minimum amounts specified to attain PR (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). | 5/17 participants were analyzed because responses were only measured in participants with MCD. | Posted | Number | 90% Confidence Interval | percentage of participants | At end of treatment (after 18 weeks of treatment) |
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| Secondary | Response Rate of Participants With Active Multicentric Castleman Disease (MCD) Assessed by the National Cancer Institute (NCI) MCD Response Criteria Reported Along With a 95% Confidence Interval | Response rate is calculated by the percentage of participants with either a partial or complete response. Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to Kaposi sarcoma-associated herpesvirus (KSHV)-MCD must improve by the minimum amounts specified to attain PR (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). | 5/17 participants were analyzed because responses were only measured in participants with MCD. | Posted | Number | 95% Confidence Interval | percentage of participants | At end of treatment (after 18 weeks of treatment) |
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| Secondary | Kaposi's Sarcoma-associated Herpesvirus (KSHV)-Associated Inflammatory Cytokine Syndrome (KICS) Reported Along With a 90% Confidence Interval | Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to KICS, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to KICS must improve by the minimum amounts (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). Progressive disease (PD) is at least two indicator abnormalities must deteriorate by the minimum amounts specified below to constitute PD (e.g., C-reactive protein increase by ≥50% of baseline (or the upper limit of normal, whichever is greater); Hemoglobin decrement 2g/dL not otherwise explained; and Platelet decrement ≥25,000/mm^3 not otherwise explained). Stable disease (SD) is no change in signs and symptoms of KICS that meet criteria for any of CR, PR or PD. | This outcome was not done because the definition of KSHV-inflammatory Cytokine syndrome (KICS) has been updated to exclude participants with lymphoma and therefore, effect of the regimen on KICS cannot be performed. | Posted | At the end of treatment (after 18 weeks of treatment) |
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| Secondary | Kaposi's Sarcoma-associated Herpesvirus (KSHV)-Associated Inflammatory Cytokine Syndrome (KICS) Reported Along With a 95% Confidence Interval | Complete Response (CR) is full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to KICS, lasting at least 3 weeks. Partial Response (PR) is at least 50% of the abnormalities probably or definitely attributed to KICS must improve by the minimum amounts (e.g., C-reactive protein reduction to ≤50% of baseline; and Hemoglobin increment 2g/dL not explained by transfusion). Progressive disease (PD) is at least two indicator abnormalities must deteriorate by the minimum amounts specified below to constitute PD (e.g., C-reactive protein increase by ≥50% of baseline (or the upper limit of normal, whichever is greater); Hemoglobin decrement 2g/dL not otherwise explained; and Platelet decrement ≥25,000/mm^3 not otherwise explained). Stable disease (SD) is no change in signs and symptoms of KICS that meet criteria for any of CR, PR or PD. | This outcome was not done because the definition of KSHV-inflammatory Cytokine syndrome (KICS) has been updated to exclude participants with lymphoma and therefore, effect of the regimen on KICS cannot be performed. | Posted | At the end of treatment (after 18 weeks of treatment) |
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| Secondary | Pharmacokinetics of Lenalidomide in Blood | Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in blood using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program. | Not Posted | Dec 2026 | Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days) | Participants | ||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Lenalidomide Effusion | Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in effusions using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program. | The objective of obtaining effusion-based PKs can only be done if effusions within a cavity are visible after treatment and safe to proceed. Safety is paramount in this Phase I study and therefore if there was no effusion and/or if it was not safe to sample based on investigator judgement, no samples could be obtained, and no PKs could be obtained to answer this objective. There is no data collected for this measure of effusion PKs. | Posted | Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days) |
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| Secondary | Pharmacokinetics of Lenalidomide in Cerebrospinal Fluid (CSF) | Bioanalytical measurements will be conducted on an ultra-high-performance liquid chromatography (uHPLC) with tandem mass spectrometric detection to determine the concentration of lenalidomide in CSF using an assay developed and validated by the National Institutes of Health (NIH) Clinical Pharmacology Program. | Not Posted | Dec 2026 | Cycle 1 Day 1(C1D1), C1D7, C6D1 (one cycle = 21 days) | Participants | ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With a Dose-limiting Toxicity (DLT) | DLT's as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). DLT is defined as any grade 4 adverse event at least possibly related to lenalidomide and not probably or definitely related to human immunodeficiency virus (HIV) or a Kaposi sarcoma-associated herpesvirus (KSHV)associated malignancy resulting in a dose delay in etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) treatment >2 weeks due to failure to resolve to grade 3 or lower. Any grade 3 cardiac toxicity that is at least possibly related to lenalidomide and not probably or definitely related to HIV or a KSHV-associated malignancy resulting in a dose delay in DA-EPOCH-R treatment >2 weeks due to failure to resolve to grade 2 or lower. DLT's were used to determine whether to stop or hold therapy in an individual participant as well as to expand individual dose levels from 3 to 6 participants. | 6/17 participants were analyzed because dose-limiting toxicity was only performed during phase I which was only 6 participants. | Posted | Count of Participants | Participants | First 6 weeks (2 cycles) of treatment |
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| Other Pre-specified | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Posted | Count of Participants | Participants | Median follow-up time was 26 months |
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All-Cause Mortality was monitored/assessed for a median or 26 months. Adverse Events was monitored/assessed from the first study treatment through 30 days after the study agent (s) was/were administered.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab | Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m^2/day, Vincristine 0.4 mg/m^2 /day, and Doxorubicin 10 mg /m^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6. | 3 | 17 | 12 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Disease progression | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Enterocolitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypothermia | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vascular disorders - Other, DVT upper extremities, bilateral | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vascular disorders - Other, Pulmonary emboly, LUL | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vascular disorders - Other, Pulmonary emboly, RLL | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| CPK increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cardiac disorders - Other, specify: Tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cardiac disorders - Other, specify: shock | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Ear and labyrinth disorders - Other, specify: Ear infection | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema trunk | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Eye disorders - Other, specify: Photophobia | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify: Gastric obstruction | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Body aches | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Burning top of the feet | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Facial rash | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Imbalance | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Left Knee effusion | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Nodule, right breast | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Rash forehead | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Runny nose | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify: CMV viremia | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Epiglottitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other, specify: DVT-LUA axillary/basilica vein | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Periorbital edema | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify: Uric acid increased | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify: Urine protein increased | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify: Runny nose | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: Brittle nails | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: Darkening of skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Vascular disorders - Other, specify: Pulmonary emboly, LUL | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vascular disorders - Other, specify: Pulmonary emboly, RLL | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ramya Ramaswami | National Cancer Institute | 240-506-1088 | ramya.ramaswami@nih.gov |
| May 7, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2023 | May 7, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054685 | Lymphoma, Primary Effusion |
| D016393 | Lymphoma, B-Cell |
| D016483 | Lymphoma, AIDS-Related |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
|---|---|
| D000077269 | Lenalidomide |
| D000069283 | Rituximab |
| D011241 | Prednisone |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D004317 | Doxorubicin |
| C506643 | liposomal doxorubicin |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D004562 | Electrocardiography |
| D004452 | Echocardiography |
| D014463 | Ultrasonography |
| D001999 | Bronchoscopy |
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D003948 | Diagnostic Techniques, Respiratory System |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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 |
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