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Study stopped early due to low patient accrual.
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This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.
This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab vedotin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | 1.8 mg/kg given intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR | Up to 18.3 months |
| Number of Participants With Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. | Up to 36 months |
| Number of Participants With Laboratory Abnormalities | Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. | Up to 17.1 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominic Lai, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Medical Center | Anaheim | California | 92801 | United States | ||
| SCL Health Good Samaritan Medical Center Cancer Centers of Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | Classic Hodgkin Lymphoma | Participants with classic Hodgkin lymphoma |
| FG001 | PTCL | Participants with peripheral T cell lymphoma |
| 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 | Apr 28, 2020 | Aug 3, 2023 |
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| Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. | up to 18.3 months |
| Overall Survival (OS) | OS is defined as the time from date of enrollment to date of death due to any cause. | Up to 35.8 months |
| Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) | Up to 18.3 months |
| ORR Per Investigator Assessment According to Modified Lugano Response Criteria | Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment | Up to 18.3 months |
| DOR Per Investigator Assessment According to Modified Lugano Response Criteria | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. | Up to 17.1 months |
| Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. | Up to 18.3 months |
| Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria | CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014). | Up to 18.3 months |
| ORR Per BICR According to Lugano Response Criteria | ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014) | Up to 18.3 months |
| Lafayette |
| Colorado |
| 80026 |
| United States |
| Memorial Cancer Institute | Pembroke Pines | Florida | 33028 | United States |
| Northwest Oncology and Hematology/AMITA | Elk Grove Village | Illinois | 60007 | United States |
| Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | United States |
| Saint Louis University | St Louis | Missouri | 63103 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Summit Medical Group | Florham Park | New Jersey | 07932 | United States |
| Medical University of South Carolina/Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| Texas Oncology - Fort Worth | Dallas | Texas | 75246 | United States |
| Texas Oncology - Fort Worth 12th Avenue | Fort Worth | Texas | 76104 | United States |
| The Center for Cancer and Blood Disorders: Fortworth | Fort Worth | Texas | 76104 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4095 | United States |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | United States |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78240 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set includes participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Classic Hodgkin Lymphoma | Participants with classic Hodgkin lymphoma |
| BG001 | PTCL | Participants with peripheral T cell lymphoma |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Number | 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 | Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 18.3 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Number | Participants | Up to 36 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. | The full analysis set includes participants who received at least one dose of study treatment. This is a subset analysis of participants with complete response or partial response. | Posted | Median | 95% Confidence Interval | months | Up to 17.1 months |
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Abnormalities | Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter. | Posted | Count of Participants | Participants | Up to 36 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | up to 18.3 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from date of enrollment to date of death due to any cause. | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 35.8 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 18.3 months |
|
| |||||||||||||||||||||||||||||
| Secondary | ORR Per Investigator Assessment According to Modified Lugano Response Criteria | Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 18.3 months |
|
| |||||||||||||||||||||||||||||
| Secondary | DOR Per Investigator Assessment According to Modified Lugano Response Criteria | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. | The full analysis set includes participants who received at least one dose of study treatment. This is a subset analysis of participants with complete response or partial response. | Posted | Median | 95% Confidence Interval | Months | Up to 17.1 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 18.3 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria | CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014). | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 18.3 months |
|
| |||||||||||||||||||||||||||||
| Secondary | ORR Per BICR According to Lugano Response Criteria | ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014) | The full analysis set includes participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 18.3 months |
|
|
Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 36 months
The population for All-Cause Mortality includes all enrolled participants. The population for Serious Adverse Events and Other Adverse Events includes participants who received at least one dose of study treatment..
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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 | Classic Hodgkin Lymphoma | Participants with classic Hodgkin lymphoma | 0 | 6 | 0 | 5 | 5 | 5 |
| EG001 | PTCL | Participants with peripheral T cell lymphoma | 2 | 6 | 2 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis norovirus | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seagen Inc. | (855) 473-2436 | medinfo@seagen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2020 | Sep 15, 2023 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| 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 |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| >=65 years |
|
| 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 |
|
| Grade 1 |
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