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Study was terminated due to Sponsor decision.
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This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab | Experimental | Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days) |
|
| Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV | Experimental | Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days) Note: This arm did not enroll any participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mosunetuzumab SC | Drug | Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events - Phase 1b | From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks) | |
| Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2 | Up to Cycle 17 (cycle length = 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Best ORR as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b | Best ORR is defined as the fraction of participants with complete response (CR) or partial response (PR) at any time as determined by the investigator using Lugano 2014 criteria. | Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| University of Michigan |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W). |
| 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 | Feb 20, 2023 |
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| Tiragolumab | Drug | Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days) |
|
| Atezolizumab | Drug | Participants will receive IV atezolizumab Q3W for up to 17 treatment cycles (cycle length = 21 days) |
|
| Tocilizumab | Other | Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events |
|
| Serum Concentration of Mosunetuzumab - Phase 1b | Cycle 1 Day 1 - Cycle 8 Day 1 (cycle length = 21 days) |
| Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b | Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days) |
| Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b and Phase 2 | From the first occurrence of a documented response (CR or partial response (PR)) to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) |
| Progression-Free Survival (PFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2 | From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) |
| Event-Free Survival (EFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2 | From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) |
| Overall Survival (OS) - Phase 2 | From the time of first study treatment to death from any cause (up to approximately 4 years) |
| Percentage of Participants With Adverse Events - Phase 2 | From the start of treatment until 90 days after the final dose of study treatment |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Lifespan Cancer Institute | Providence | Rhode Island | 02905 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Eastern Health | Box Hill | Victoria | Australia |
| St Vincent's Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| AZ Sint Jan Brugge Oostende AV | Bruges | 8000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU UCL Namur - Mont-Godinne | Yvoir | 5530 | Belgium |
| Tom Baker Cancer Centre-Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 1Z5 | Canada |
| Universitaet Duisburg-Essen | Essen | 45122 | Germany |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Royal Marsden Hospital - Institute of Cancer Research - Chelsea | London | SE3 6JJ | United Kingdom |
| Plymouth Hospitals NHS Trust - Derriford Hospital | Plymouth | United Kingdom |
| Royal Marsden Hospital - Institute of Cancer Research - Sutton | Sutton | SM2 5PT | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W). |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events - Phase 1b | Posted | Number | Percentage of participants | From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2 | This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected). | Posted | Up to Cycle 17 (cycle length = 21 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Best ORR as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b | Best ORR is defined as the fraction of participants with complete response (CR) or partial response (PR) at any time as determined by the investigator using Lugano 2014 criteria. | Posted | Number | Percentage of participants | Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days) |
|
| ||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Mosunetuzumab - Phase 1b | The PK population included all participants with at least one serum sample post-dose for mosunetuzumab. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Cycle 1 Day 1 - Cycle 8 Day 1 (cycle length = 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b | Posted | Number | Percentage of participants | Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b and Phase 2 | Phase 1b is reported. No data was collected for Phase 2. | Posted | Number | Time | From the first occurrence of a documented response (CR or partial response (PR)) to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) |
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2 | This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected). | Posted | From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2 | This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected). | Posted | From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Phase 2 | This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected). | Posted | From the time of first study treatment to death from any cause (up to approximately 4 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events - Phase 2 | This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected). | Posted | From the start of treatment until 90 days after the final dose of study treatment |
|
|
From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
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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 | Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W). | 5 | 8 | 2 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebellar haematoma | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malignant dysphagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Rhinovirus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
Early termination led to small numbers of participants for analysis.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| Aug 30, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000730814 | Tiragolumab |
| C000594389 | atezolizumab |
| C502936 | tocilizumab |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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