LymphomaPhase 2NCT05673785
A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
A Phase 2 study testing Brentuximab Vedotin, Cyclophosphamide and Doxorubicin in people with Lymphoma, run by Takeda at 16 sites in China.
Trial summary
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: Side effect from the A+CHP Check how much A+CHP stays in their blood over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Brentuximab Vedotin, Cyclophosphamide and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 16 sitesChina
- Study dates
- 10 Feb 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- ALK-positive systemic anaplastic large cell lymphoma (sALCL) with an International Prognostic Index (IPI) score of ≥2.
- ALK-negative sALCL.
- PTCL- not otherwise specified (NOS).
- Angioimmunoblastic T-cell lymphoma (AITL).
- Enteropathy associated T-cell lymphoma (EATL).
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- Hepatosplenic T-cell lymphoma (HSTCL).
- 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:
- Total bilirubin must be ≤1.5 times the upper limit of normal (ULN) or ≤3 times the ULN for participants with Gilbert's disease or documented hepatic involvement with lymphoma.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤3 times the ULN or ≤5 times the ULN for participants with an elevation that can be reasonably ascribed to the presence of metastatic disease in liver.
- Serum creatinine must be <2.0 milligram per deciliter (mg/dL) and/or creatinine clearance or calculated creatinine clearance >40 milliliter (mL)/minute.
- Hemoglobin must be ≥8 grams per deciliter (g/dL). (Red blood cell transfusion is allowed ≥14 days before assessment.)
- Absolute neutrophil count >1.5×10^9/liter (L).
- Platelet count ≥75×10^9/L (unless documented bone marrow involvement with lymphoma).
Who cannot join
- 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.
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- Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
- Left-ventricular ejection fraction <45%.
- Myocardial infarction within 6 months of enrollment.
- New York Heart Association Class III or IV heart failure.
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Cancer Hospital
Beijing, 100142
Peking University Third Hospital
Beijing, 100191
The First Hospital of Jilin University
Changchun, 130021
West China Hospital, Sichuan University
Chengdu, 610041
Chongqing University Cancer Hospital
Chongqing, 400030
Fujian Medical University Union Hospital
Fuzhou, 350001
Guangdong Provincial Peoples Hospital
Guangzhou, 510080
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, 310003
Anhui Provincial Cancer Hospital
Hefei, 230088
Shandong Cancer Hospital
Jinan, 250117
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
Fudan University Shanghai Cancer Center
Shanghai, 200032
Shengjing Hospital of China Medical University
Shenyang, 110022
The First Affiliated Hospital of Soochow University
Suzhou, 215004
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
Henan Cancer Hospital
Zhengzhou, 450003
About this study
Official title: A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
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:
- Side effect from the A+CHP
- Check how much A+CHP stays in their blood over time. This will help Takeda to work out the best dose to give people in the future.
- If A+CHP improves outcome of newly diagnosed CD30+ PTCL
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.
Read the detailed description
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.
- Conditions
- Lymphoma
- Being tested
- Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone
- Keywords
- Drug Therapy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Brentuximab vedotin IV infusion
CyclophosphamideDrug
Cyclophosphamide IV infusion
DoxorubicinDrug
Doxorubicin IV infusion
PrednisoneDrug
Prednisone tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Brentuximab Vedotin; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 7 months
Number of Participants With Abnormal Changes From Baseline in Vital Sign Measurements (Blood Pressure)
Measured: Up to approximately 7 months
Secondary outcomes (17)
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.
Measured: Up to approximately 7 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start10 Feb 2023
- Primary completion27 Apr 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673785
- Sponsor's protocol ID
- C25024
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2023
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
- ClinicalTrials.gov ID
- NCT05673785
- Acronym / sponsor ID
- C25024
- Conditions
- Lymphoma
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 27 Apr 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Side effect from the A+CHP
- Check how much A+CHP stays in their blood over time. This will help Takeda to work out the best dose to give people in the future.
- If A+CHP improves outcome of newly diagnosed CD30+ PTCL
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab Vedotin + CHP | Experimental | Drug: Brentuximab Vedotin, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: PrednisoneBrentuximab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentuximab VedotinBrentuximab vedotin IV infusion | Drug | Brentuximab Vedotin + CHP |
| CyclophosphamideCyclophosphamide IV infusion | Drug | Brentuximab Vedotin + CHP |
| DoxorubicinDoxorubicin IV infusion | Drug | Brentuximab Vedotin + CHP |
| PrednisonePrednisone tablets | Drug | Brentuximab Vedotin + CHP |
Primary outcome
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma
Time frame: Up to approximately 7 months
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.
Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 7 months
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.
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements
Time frame: Up to approximately 7 months
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.
Number of Participants With Abnormal Changes From Baseline in Vital Sign Measurements (Blood Pressure)
Time frame: Up to approximately 7 months
17 secondary outcomes
CR Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma
Time frame: Up to approximately 7 months
1-Year Progression Free Survival (PFS) Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma
Time frame: Month 12
1-Year Overall Survival (OS) Rate
Time frame: Month 12
ORR by IRF Per 2014 Lugano Classification
Time frame: Up to approximately 7 months
ORR by Investigator Assessment Per 2014 Lugano Classification
Time frame: Up to approximately 7 months
CR Rate by IRF Per 2014 Lugano Classification
Time frame: Up to approximately 7 months
CR Rate by Investigator Assessment Per 2014 Lugano Classification
Time frame: Up to approximately 7 months
Time to Response (TTR) by IRF Per 2014 Lugano Classification
Time frame: Up to approximately 7 months
Time to Response (TTR) by Investigator Assessment Per 2014 Lugano Classification
Time frame: Up to approximately 7 months
1-Year PFS Rate by IRF Per 2014 Lugano Classification
Time frame: Month 12
1-Year PFS Rate by Investigator Assessment Per 2014 Lugano Classification
Time frame: Month 12
Duration of Response (DOR) by Investigator Assessment Per 2014 Lugano Classification
Time frame: Up to approximately 36 months
Serum Antibody-Drug Conjugate (ADC) Concentration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brentuximab Vedotin, Cyclophosphamide and Doxorubicin in people with Lymphoma, run by Takeda at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma (time frame: Up to approximately 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.