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Sponsor decision based on portfolio prioritization
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This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| denintuzumab mafodotin + RCHOP | Experimental | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) |
|
| denintuzumab mafodotin + RCHP | Experimental | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) |
|
| denintuzumab mafodotin + RCHOP or RCHP | Experimental | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP |
|
| RCHOP | Active Comparator | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denintuzumab mafodotin | Drug | SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Part B Outcome Measure: Complete Response Rate (CR) | Study did not progress to Part B. | N/A - Endpoint not assessed |
| Part A and Part B Outcome Measure: Incidence of Adverse Events | Part A data only; study did not progress to Part B. | 54.7 weeks |
| Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities | Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported. | Up to 183 days |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) Between Study Arms in Part B | Study did not progress to Part B | N/A - Endpoint not assessed |
| Progression-free Survival (PFS) Between Study Arms in Part B | Study did not progress to Part B. |
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Inclusion Criteria:
Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;
Tumor tissue available from most recent biopsy to determine cell of origin
Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
Eastern Cooperative Oncology Group performance status ≤2
Age 18 years or older
Adequate study baseline laboratory parameters
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Pinelli, PA-C, MMSc. | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Saint Bernards Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Denintuzumab Mafodotin + RCHP | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| 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 | Yes | No | No | Study Protocol | Feb 18, 2016 | Dec 14, 2018 |
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| rituximab | Drug | 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles |
|
| cyclophosphamide | Drug | 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles |
|
| doxorubicin | Drug | 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles |
|
| vincristine | Drug | 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) |
|
| prednisone | Drug | 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
|
| N/A - Endpoint not assessed |
| Overall Survival (OS) Between Study Arms in Part B | Study did not progress to Part B. | N/A - Endpoint not assessed |
| Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B | Study did not progress to Part B. | N/A - Endpoint not assessed |
| Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B | Study did not progress to Part B. | N/A - Endpoint not assessed |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| City of Hope | Duarte | California | 91010 | United States |
| Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California | 92708 | United States |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States |
| University of Colorado Health Memorial Hospital | Colorado Springs | Colorado | 80909 | United States |
| Poudre Valley Hospital Harmony Campus | Fort Collins | Colorado | 80528 | United States |
| Central Georgia Cancer Care | Macon | Georgia | 31201 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Montgomery Cancer Center | Mount Sterling | Kentucky | 40353 | United States |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70122 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Hattiesburg Clinic (Forrest General Hospital) | Hattiesburg | Mississippi | 39401 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Montefiore Medical Center - Bronx | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Regional Medical Oncology Center | Wilson | North Carolina | 27893 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| University Hospitals Seidman Cancer Center | Cleveland | Ohio | 44106 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| Tennessee Oncology / Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Baylor Health - Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| Scott and White Memorial Hospital - Temple | Temple | Texas | 76508 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Vista Oncology INC PS | Olympia | Washington | 98502 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| Ponce Medical School Foundation | Ponce | 00716 | Puerto Rico |
| FG001 | Denintuzumab Mafodotin + RCHOP | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| FG002 | Denintuzumab Mafodotin + RCHOP or RCHP | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| FG003 | RCHOP | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Denintuzumab Mafodotin + RCHP | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| BG001 | Denintuzumab Mafodotin + RCHOP | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Measure Description: 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed <50% of the time; 3= In bed >50% of the time; 4=100% bedridden; 5=Dead | 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 | Part B Outcome Measure: Complete Response Rate (CR) | Study did not progress to Part B. | Endpoint not assessed; study did not progress to Part B. | Posted | N/A - Endpoint not assessed |
|
| ||||||||||||||||||||||||||||
| Primary | Part A and Part B Outcome Measure: Incidence of Adverse Events | Part A data only; study did not progress to Part B. | Posted | Count of Participants | Participants | 54.7 weeks |
| ||||||||||||||||||||||||||||
| Primary | Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities | Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported. | Posted | Count of Participants | Participants | Up to 183 days |
| ||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) Between Study Arms in Part B | Study did not progress to Part B | Endpoint not assessed; study did not progress to Part B. | Posted | N/A - Endpoint not assessed |
| |||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Between Study Arms in Part B | Study did not progress to Part B. | Endpoint not assessed; study did not progress to Part B. | Posted | N/A - Endpoint not assessed |
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Between Study Arms in Part B | Study did not progress to Part B. | Endpoint not assessed; study did not progress to Part B. | Posted | N/A - Endpoint not assessed |
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B | Study did not progress to Part B. | Endpoint not assessed; study did not progress to Part B. | Posted | N/A - Endpoint not assessed |
| |||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B | Study did not progress to Part B. | Endpoint not assessed; study did not progress to Part B. | Posted | N/A - Endpoint not assessed |
|
54.7 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 | Denintuzumab Mafodotin + RCHP | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | 2 | 11 | 5 | 11 | 11 | 11 |
| EG001 | Denintuzumab Mafodotin + RCHOP | Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles | 2 | 13 | 4 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Keratopathy | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ocular toxicity | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Corneal dystrophy | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Corneal epithelium defect | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Corneal opacity | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye infection fungal | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Eye oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
Study was ended by sponsor prior to Part B enrollment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seattle Genetics, Inc. | 855-473-2436 | medinfo@seagen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2018 | Dec 14, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D006402 | Hematologic Diseases |
| D007154 | Immune System Diseases |
| D007160 | Immunoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009369 | Neoplasms |
| D009370 | Neoplasms by Histologic Type |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1: Symptoms, but ambulatory |
|
| 2: In bed less than 50% of the time |
|
|
|
|
|
| OG002 | Denintuzumab Mafodotin + RCHOP or RCHP | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| OG003 | RCHOP | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
|
| OG002 | Denintuzumab Mafodotin + RCHOP or RCHP | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| OG003 | RCHOP | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
|
| OG002 | Denintuzumab Mafodotin + RCHOP or RCHP | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| OG003 | RCHOP | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
|
| OG002 | Denintuzumab Mafodotin + RCHOP or RCHP | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| OG003 | RCHOP | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
|
| OG002 | Denintuzumab Mafodotin + RCHOP or RCHP | Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
| OG003 | RCHOP | Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total) prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles |
|