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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1184-1838 | Other Identifier | WHO |
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The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+ Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).
The drug being tested in this study is called brentuximab vedotin. This study will look at efficacy, safety and PK of brentuximab vedotin in Chinese participants with relapsed/refractory CD30+ HL or sALCL.
The study will enroll approximately 30 patients. Participants will receive:
• Brentuximab vedotin 1.8 mg/kg
All participants will be administered IV infusion on Day 1 each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles.
This multi-center trial will be conducted in China only. The overall time to participate in this study is 3.5 years. Participants will make multiple visits to the clinic, and will be followed for overall survival (OS) every 12 weeks until death, withdrawal of consent, 18 months after end of treatment (EOT) or study closure, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab Vedotin 1.8 mg/kg | Experimental | Brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab Vedotin | Drug | Brentuximab vedotin IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who have achieved complete remission (CR)=disappearance of all evidence of disease or partial remission (PR)=regression of greater than or equal to 50% of measurable disease and no new site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug. | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) |
| Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | Clinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events. Neutropenia (pooled) includes preferred terms Neutropenia and Neutrophil count decreased. | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) |
| Number of Participants With Abnormal Vital Signs Reported as Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) Rate | CR rate is defined as the percentage of participants who have achieved CR by EOT. CR is defined as disappearance of all evidence of disease per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months) |
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Inclusion Criteria:
Have histologically confirmed CD30+ hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (sALCL). Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease, and pathology reports of CD30+ or their copies should be retained at the site.
With CD30+ HL or sALCL who have relapsed from or are refractory to previous treatments.
Fluorodeoxyglucose (FDG)- positron emission tomography (PET) positive and measurable disease of at least 1.5 cm in the longest diameter by computed tomography (CT), as assessed by the site.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
Must have the following required screening laboratory data. Participants must not have received recombinant granulocyte-colony stimulating factor (G-CSF) or platelet transfusion within 1 week before the screening hematology assessment.
Survival for 3 or more months must be expected.
Exclusion Criteria:
With current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL) (participants with other organ involvement who have transformed to sALCL are eligible).
With any active viral, bacterial, or fungal infection within 2 weeks before the first dose of brentuximab vedotin.
With cardiac failure categorized as Class III or IV according to the New York Heart Association criteria, uncontrolled coronary artery disease or uncontrolled arrhythmia despite of appropriate medical therapy, or a history of myocardial infarction within 6 months before the first dose of brentuximab vedotin.
With uncontrolled diabetes mellitus.
Peripheral neuropathy ≥Grade 2.
With a history of another malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit:
With known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
With a positive result in the screening test for human immunodeficiency virus (HIV) antibody.
Known hepatitis B virus (HBV) surface antigen seropositive or positive hepatitis C virus (HCV) antibody. Note: participants who have positive HBV core antibody can be enrolled but must have an undetectable HBV viral load.
With a history of liver fibrosis or cirrhosis and clinical signs and symptoms indicating liver fibrosis or cirrhosis.
Have received autologous stem cell transplantation (auto-SCT) within 12 weeks before the first dose of brentuximab vedotin.
With history of allogeneic stem cell transplantation (allo-SCT).
Have received treatment for malignancies (including radiation, chemotherapy, and hormone therapy) within 4 weeks before the first dose of brentuximab vedotin and participants who have received treatment for malignancies with biologics (including molecular target drug) or radioisotopic therapy within 12 weeks before the first dose of brentuximab vedotin.
Have unresolved toxicity higher than Grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03) attributed to any prior therapy/procedure (excluding alopecia or non-clinically significant and asymptomatic laboratory abnormalities).
Have received systemic corticosteroids at doses greater than the equivalent of 20 mg/day of prednisone within 1 week before the first dose of brentuximab vedotin.
Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of the safety and toxicity of the prescribed regimens.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Peking University Third Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34275403 | Derived | Song Y, Guo Y, Huang H, Li W, Ke X, Feng J, Xu W, Miao H, Kinley J, Song G, Dai Y, Wang H, Zhu J. Phase II single-arm study of brentuximab vedotin in Chinese patients with relapsed/refractory classical Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Expert Rev Hematol. 2021 Sep;14(9):867-875. doi: 10.1080/17474086.2021.1942831. Epub 2021 Aug 24. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL) were enrolled to receive brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion, Day 1 of every 3-week cycle.
Participants took part in the study at 7 investigative sites in China. The study was conducted from 07 November 2016 to 3 February 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin 1.8 mg/kg (HL) | Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL). |
| FG001 |
| 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 20, 2016 | Jul 23, 2019 |
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Vital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events.
| First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) |
| Duration of Response (DOR) | DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites. | Up to 3.2 years |
| Progression Free Survival (PFS) | PFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. | Up to 3.2 years |
| Overall Survival (OS) | Overall survival is defined as the time from the start of treatment to the date of death. | Up to 3.2 years |
| B Symptom Resolution Rate | B Symptom Resolution Rate is defined as the percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period. | Day 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months) |
| Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb) | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE) | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brentuximab Vedotin ADC | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC | Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAb | Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| AUC(0-∞): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MMAE | Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
| Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin | Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test to determine ATA titers. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-baseline confirmed ATA positive responses) and by nATA status. The number of participants in each baseline ATA and post-baseline ATA categories are reported. | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression, death or end of treatment (approximately 12 months) |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| Sun Yat-san University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
| Jiangsu Province People's Hospital | Nanjing | Jiangsu | 210029 | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200010 | China |
| Brentuximab Vedotin 1.8 mg/kg (sALCL) |
Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL). |
| COMPLETED | Completed included participants who completed 16 cycles of treatment with brentuximab vedotin and 18-months post-treatment follow-up. |
|
| NOT COMPLETED |
|
|
Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximab Vedotin 1.8 mg/kg (HL) | Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL). |
| BG001 | Brentuximab Vedotin 1.8 mg/kg (sALCL) | Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL). |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | Overall Response Rate (ORR) | ORR is defined as the percentage of participants who have achieved complete remission (CR)=disappearance of all evidence of disease or partial remission (PR)=regression of greater than or equal to 50% of measurable disease and no new site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | Modified Intent-to-Treat (mITT) Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months) |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug. | Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Posted | Count of Participants | Participants | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) |
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| Primary | Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | Clinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events. Neutropenia (pooled) includes preferred terms Neutropenia and Neutrophil count decreased. | Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Posted | Count of Participants | Participants | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) |
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| Primary | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | Vital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events. | Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Posted | Count of Participants | Participants | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) |
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| Secondary | Complete Remission (CR) Rate | CR rate is defined as the percentage of participants who have achieved CR by EOT. CR is defined as disappearance of all evidence of disease per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months) |
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| Secondary | Duration of Response (DOR) | DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites. | mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. Only responders were analyzed for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Up to 3.2 years |
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| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. | mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Posted | Median | 95% Confidence Interval | months | Up to 3.2 years |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from the start of treatment to the date of death. | mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Posted | Median | 95% Confidence Interval | months | Up to 3.2 years |
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| Secondary | B Symptom Resolution Rate | B Symptom Resolution Rate is defined as the percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period. | Participants from the mITT Population, all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin, who had lymphoma-related B symptoms at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months) |
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| Secondary | Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) | Pharmacokinetic (PK)-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | Posted | Mean | Standard Deviation | micrograms/milliliter (ug/mL) | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb) | PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | Posted | Mean | Standard Deviation | ug/mL | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE) | PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | Posted | Mean | Standard Deviation | ug/mL | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brentuximab Vedotin ADC | PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | Posted | Median | Full Range | days | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb | PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | Posted | Median | Full Range | days | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE | PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | Posted | Median | Full Range | days | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC | Participants from the PK-evaluable Populations, participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist, with data available for analysis. | Posted | Mean | Standard Deviation | day*ug/mL | Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAb | PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | Posted | Mean | Standard Deviation | day*ug/mL | Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | AUC(0-∞): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MMAE | PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | Posted | Mean | Standard Deviation | day*ug/mL | Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
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| Secondary | Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin | Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test to determine ATA titers. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-baseline confirmed ATA positive responses) and by nATA status. The number of participants in each baseline ATA and post-baseline ATA categories are reported. | Immunogenicity Population included participants who received at least 1 dose of brentuximab vedotin and had ATA status assessment at baseline, and at least 1 postbaseline sample. Number analyzed is the number of participants with data available. | Posted | Count of Participants | Participants | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression, death or end of treatment (approximately 12 months) |
|
All-Cause Mortality: up to 3.2 years; Serious and Other Adverse Events: First dose of study drug up to 30 days post last dose of study drug (up to 12 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to 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 | Brentuximab Vedotin 1.8 mg/kg (HL) | Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL). | 4 | 30 | 1 | 30 | 30 | 30 |
| EG001 | Brentuximab Vedotin 1.8 mg/kg (sALCL) | Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL). | 3 | 9 | 1 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Large intestine polyp | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Total bile acids increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Reticulocyte count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Reticulocyte count increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Lymphocyte percentage decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Lymphocyte percentage increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Retinol binding protein increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood urea decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| High density lipoprotein decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Lipoprotein (a) increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment | Neutropenia includes preferred terms Neutropenia and Neutrophil count decreased. |
|
| Monocytosis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2018 | Jul 23, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
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