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This study will use a combination of Brentuximab vedotin with CHP to treat adult Chinese participants with CD30+ PTCL.
The main aims of the study are to evaluate:
Brentuximab vedotin will be given through vein on Day 1 of each 21-day cycle. Cyclophosphamide and doxorubicin will be given through vein. Prednisone will be given orally daily on Days 1 through 5.
The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat CD30+ PTCL in Chinese participants. This study will look at the efficacy, safety, and pharmacokinetics (PK) of A+CHP as frontline treatment for newly diagnosed CD30+ PTCL.
The study will enroll approximately 52 participants. Participants will be enrolled in a single group to receive:
• Brentuximab vedotin 1.8 milligrams per kilogram (mg/kg) + Cyclophosphamide 750 milligrams per square meter (mg/m^2), Doxorubicin 50 mg/m^2 and Prednisone 100 mg
This multi-center trial will be conducted in China. The overall time to participate in this study is approximately 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab Vedotin + CHP | Experimental | Brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m^2 and doxorubicin 50 mg/m^2 IV, on Day 1 of each 21-day cycle, and prednisone 100 milligram (mg) tablets, orally, on Days 1 through Day 5, for up to 8 cycles (6 months) or until progressive disease (PD), unacceptable toxicity, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab Vedotin | Drug | Brentuximab vedotin IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma | ORR by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF assessment using the International Working Group (IWG) Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | Up to approximately 7 months |
| Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., 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 TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 30 days after the last dose of study treatment. | Up to approximately 7 months |
| Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements | Laboratory parameters like Potassium, Aspartate Aminotransferase (AST), Bilirubin, Serum Gamma-glutamyl Transferase (GGT), High Glucose (Hyperglycemia), Neutrophils, Leukocytes, Platelets, and Hemoglobin were assessed. Intensity of changes in laboratory parameters were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Up to approximately 7 months |
| Number of Participants With Abnormal Changes From Baseline in Vital Sign Measurements (Blood Pressure) | Up to approximately 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| CR Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma | CR rate by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a CR by IRF assessment using the IWG Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease. | Up to approximately 7 months |
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Inclusion Criteria:
Participants must have newly diagnosed CD30+ PTCL, per the Revised European American Lymphoma 2016 World Health Organization (WHO) classification, by local assessment. Tumor specimen must be submitted before enrollment for subsequent central pathology review to confirm histology (and anaplastic lymphoma kinase (ALK) status, if applicable), and CD30 expression. Eligible histologies include:
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) imaging and measurable disease with at least 1 bidimensionally measurable lesion (>1.5 cm in its largest dimension) by computed tomography (CT).
Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and immunogenicity sampling.
Clinical laboratory values as specified below at screening/baseline within 7 days before the first dose of study drug:
Exclusion Criteria:
Systemic anticancer therapy, including traditional Chinese medicine with antitumor indication for disease under study before the first dose of study drugs.
Major surgery within 28 days before the first dose of study drug.
Known human immunodeficiency virus (HIV)-positive status.
Known hepatitis B virus (HBV) surface antigen (HBsAg) seropositivity or active hepatitis C virus infection.
Note: Participants who have positive HBV core antibody and are HBsAg negative can be enrolled, but must have an undetectable HBV viral load.
Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
Participants with current diagnosis of primary cutaneous CD30+ T-cell lymphoproliferative disorders and lymphomas. Participants with cutaneous anaplastic large cell lymphoma (ALCL) with extracutaneous tumor spread beyond locoregional lymph nodes are eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible).
Participants with mycosis fungoides (MF) [including transformed MF].
Uncontrolled diabetes mellitus.
Baseline peripheral neuropathy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version 5.0).
History of progressive multifocal leukoencephalopathy (PML).
Previous treatment with brentuximab vedotin or CD30 monoclonal antibody.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China | |||
| Peking University Third Hospital |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
A total of 52 participants with newly diagnosed CD30-positive (CD30+) peripheral T-cell lymphomas (PTCL) were enrolled in the study and treated with brentuximab vedotin in combination with cyclophosphamide, doxorubicin (hydroxydaunorubicin) and prednisone (CHP). The results presented are until the primary completion date.
Participants took part in the study at 14 investigative sites in China from 10 February 2023 to 27 April 2025. The study is ongoing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin + CHP | Participants received brentuximab vedotin 1.8 milligrams per kilogram (mg/kg), intravenous (IV) infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 milligrams per square meter (mg/m^2) and doxorubicin 50 mg/m^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until progressive disease (PD), unacceptable toxicity, whichever occurred first. |
| 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 | Dec 13, 2021 | Apr 30, 2026 |
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| Cyclophosphamide |
| Drug |
Cyclophosphamide IV infusion |
|
| Doxorubicin | Drug | Doxorubicin IV infusion |
|
| Prednisone | Drug | Prednisone tablets |
|
| 1-Year Progression Free Survival (PFS) Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma | The 1-year PFS rate by IRF assessment using the IWG Revised Response criteria is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first. | Month 12 |
| 1-Year Overall Survival (OS) Rate | The 1-year OS rate is defined as the percentage of participants alive at 1 year. OS is defined as the time from the start of study treatment to the date of death due to any cause. | Month 12 |
| ORR by IRF Per 2014 Lugano Classification | ORR by IRF per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | Up to approximately 7 months |
| ORR by Investigator Assessment Per 2014 Lugano Classification | ORR by investigator assessment per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | Up to approximately 7 months |
| CR Rate by IRF Per 2014 Lugano Classification | CR rate by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was defined as the percentage of participants who achieved a CR by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease. | Up to approximately 7 months |
| CR Rate by Investigator Assessment Per 2014 Lugano Classification | CR rate by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses is defined as the percentage of participants who have achieved a CR by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease | Up to approximately 7 months |
| Time to Response (TTR) by IRF Per 2014 Lugano Classification | TTR by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by IRF following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | Up to approximately 7 months |
| Time to Response (TTR) by Investigator Assessment Per 2014 Lugano Classification | TTR by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by investigator assessment following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | Up to approximately 7 months |
| 1-Year PFS Rate by IRF Per 2014 Lugano Classification | The 1-year PFS rate by IRF per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first. | Month 12 |
| 1-Year PFS Rate by Investigator Assessment Per 2014 Lugano Classification | The 1-year PFS rate by investigator assessment per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first. | Month 12 |
| Duration of Response (DOR) by Investigator Assessment Per 2014 Lugano Classification | DOR by investigator assessment using the 2014 Lugano Classification criteria is defined as the time between the first documentation of objective tumor response (CR or PR) by investigator assessment and the first subsequent documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first. | Up to approximately 36 months |
| Serum Antibody-Drug Conjugate (ADC) Concentration | Antibody-Drug Conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody with a cytotoxic drug to selectively deliver treatment to cancer cells while minimizing damage to healthy cells. | Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days |
| Plasma Monomethyl Auristatin E (MMAE) Concentration | The plasma concentration of MMAE is a critical factor in determining the efficacy and safety of ADCs. | Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days |
| Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive | Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days. |
| ADA Titer in Participants Positive for ADA Post Baseline | Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days. |
| Number of Participants With Negative and Positive Neutralizing Antibody Status (NAb) | Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days |
| Beijing |
| 100191 |
| China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| Fujian Medical University Union Hospital | Fuzhou | 350001 | China |
| Guangdong Provincial Peoples Hospital | Guangzhou | 510080 | China |
| The First Affiliated Hospital of Zhejiang University school of medicine | Hangzhou | 310003 | China |
| Anhui Provincial Cancer Hospital | Hefei | 230088 | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | 330006 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Shengjing Hospital of China Medical University | Shenyang | 110022 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | 215004 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | 300060 | China |
| Henan Cancer Hospital | Zhengzhou | 450003 | China |
| COMPLETED |
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| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) consisted of all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximab Vedotin + CHP | Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m^2 and doxorubicin 50 mg/m^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma | ORR by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF assessment using the International Working Group (IWG) Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | The FAS consisted of all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 7 months |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., 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 TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 30 days after the last dose of study treatment. | The FAS consisted of all enrolled participants. | Posted | Number | percentage of participants | Up to approximately 7 months |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements | Laboratory parameters like Potassium, Aspartate Aminotransferase (AST), Bilirubin, Serum Gamma-glutamyl Transferase (GGT), High Glucose (Hyperglycemia), Neutrophils, Leukocytes, Platelets, and Hemoglobin were assessed. Intensity of changes in laboratory parameters were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | The FAS consisted of all enrolled participants. | Posted | Count of Participants | Participants | Up to approximately 7 months |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Changes From Baseline in Vital Sign Measurements (Blood Pressure) | The FAS consisted of all enrolled participants. | Posted | Count of Participants | Participants | Up to approximately 7 months |
|
| ||||||||||||||||||||||||||||
| Secondary | CR Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma | CR rate by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a CR by IRF assessment using the IWG Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease. | The FAS consisted of all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 7 months |
|
| ||||||||||||||||||||||||||
| Secondary | 1-Year Progression Free Survival (PFS) Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma | The 1-year PFS rate by IRF assessment using the IWG Revised Response criteria is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first. | Not Posted | Dec 2028 | Month 12 | Participants | ||||||||||||||||||||||||||||||
| Secondary | 1-Year Overall Survival (OS) Rate | The 1-year OS rate is defined as the percentage of participants alive at 1 year. OS is defined as the time from the start of study treatment to the date of death due to any cause. | Not Posted | Dec 2028 | Month 12 | Participants | ||||||||||||||||||||||||||||||
| Secondary | ORR by IRF Per 2014 Lugano Classification | ORR by IRF per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | The FAS consisted of all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 7 months |
|
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| Secondary | ORR by Investigator Assessment Per 2014 Lugano Classification | ORR by investigator assessment per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | The FAS consisted of all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 7 months |
|
| ||||||||||||||||||||||||||
| Secondary | CR Rate by IRF Per 2014 Lugano Classification | CR rate by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was defined as the percentage of participants who achieved a CR by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease. | The FAS consisted of all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 7 months |
|
| ||||||||||||||||||||||||||
| Secondary | CR Rate by Investigator Assessment Per 2014 Lugano Classification | CR rate by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses is defined as the percentage of participants who have achieved a CR by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease | The FAS consisted of all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 7 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) by IRF Per 2014 Lugano Classification | TTR by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by IRF following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | The FAS consisted of all enrolled participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Median | 95% Confidence Interval | months | Up to approximately 7 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) by Investigator Assessment Per 2014 Lugano Classification | TTR by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by investigator assessment following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. | The FAS consisted of all enrolled participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Median | 95% Confidence Interval | months | Up to approximately 7 months |
|
| ||||||||||||||||||||||||||
| Secondary | 1-Year PFS Rate by IRF Per 2014 Lugano Classification | The 1-year PFS rate by IRF per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first. | Not Posted | Dec 2028 | Month 12 | Participants | ||||||||||||||||||||||||||||||
| Secondary | 1-Year PFS Rate by Investigator Assessment Per 2014 Lugano Classification | The 1-year PFS rate by investigator assessment per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first. | Not Posted | Dec 2028 | Month 12 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by Investigator Assessment Per 2014 Lugano Classification | DOR by investigator assessment using the 2014 Lugano Classification criteria is defined as the time between the first documentation of objective tumor response (CR or PR) by investigator assessment and the first subsequent documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first. | Not Posted | Dec 2028 | Up to approximately 36 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Serum Antibody-Drug Conjugate (ADC) Concentration | Antibody-Drug Conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody with a cytotoxic drug to selectively deliver treatment to cancer cells while minimizing damage to healthy cells. | The pharmacokinetic analysis set comprised of all participants who are in the FAS with at least 1 pharmacokinetic parameter. Here, "number analyzed" are the number of participants with data available for analysis at specified time-point. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days |
|
| ||||||||||||||||||||||||||
| Secondary | Plasma Monomethyl Auristatin E (MMAE) Concentration | The plasma concentration of MMAE is a critical factor in determining the efficacy and safety of ADCs. | The pharmacokinetic analysis set comprised of all participants who are in the FAS with at least 1 pharmacokinetic parameter. Here, "number analyzed" are the number of participants with data available for analysis at specified time-point. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days |
|
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| Secondary | Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive | The immunogenicity analysis set consisted of participants who received at least 1 dose of any of the study treatments and had an ADA status assessment at baseline and at least 1 postbaseline sample. | Posted | Count of Participants | Participants | Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days. |
|
| ||||||||||||||||||||||||||||
| Secondary | ADA Titer in Participants Positive for ADA Post Baseline | The immunogenicity analysis set consisted of participants who have received at least 1 dose of any of the study treatments and have had an ADA status assessment at baseline and at least 1 postbaseline sample. | Posted | Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Negative and Positive Neutralizing Antibody Status (NAb) | The immunogenicity analysis set consisted of participants who have received at least 1 dose of any of the study treatments and have had an ADA status assessment at baseline and at least 1 postbaseline sample. | Posted | Count of Participants | Participants | Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days |
|
|
AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months).
The FAS consisted of all enrolled participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brentuximab Vedotin + CHP | Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m^2 and doxorubicin 50 mg/m^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first. | 3 | 52 | 18 | 52 | 52 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Faecal occult blood positive | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Procalcitonin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2025 | Mar 20, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| 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 |
| 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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