Hodgkin DiseasePhase 2NCT02939014

Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)

A Phase 2 study testing Brentuximab Vedotin in people with Hodgkin Disease and Lymphoma, Large-Cell, Anaplastic, run by Takeda at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic
What is being tested?: Brentuximab Vedotin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 7 sitesChina
Study dates: 7 Nov 2016to 3 Feb 2020
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

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.

Show all 12Show fewer

Absolute neutrophil count ≥1500/μL.
Platelet count ≥75,000/μL.
Serum bilirubin level ≤1.5 times the upper limit of the normal range (ULN).
Serum creatinine level ≤1.5 times the ULN.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the ULN.
Survival for 3 or more months must be expected.

Who cannot join

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:

Show all 19Show fewer

Nonmelanoma skin cancer.
Curatively treated localized prostate cancer.
Cervical carcinoma in situ.
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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Hospital of Jilin University
Changchun, Jilin
Sun Yat-san University Cancer Center
Guangzhou, Guangdong, 510060
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Jiangsu Province People's Hospital
Nanjing, Jiangsu, 210029
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200010

Other trials in China

About this study

Official title: A Phase 2, Single-Arm, Open-label Study of Brentuximab Vedotin in Chinese Patients With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)

Read the detailed description

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.

Conditions: Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic
Being tested: Brentuximab Vedotin
Keywords: Drug therapy
Medical subject headings: Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic

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

Study groups in NCT02939014
Study group	Role	What they receive
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. Receives: Drug: Brentuximab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

Secondary outcomes (15)

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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 20163 Feb 2020

First posted19 Oct 2016 (estimated)
Study start7 Nov 2016
Primary completion2 Aug 2018
Study completion3 Feb 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hodgkin DiseaseStudies 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: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02939014
Sponsor's protocol ID: C25010
Other IDs: U1111-1184-1838
Status last verified: Feb 2021
First submitted: 18 Oct 2016
Last updated: 24 Feb 2021
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.

Publications

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.
PubMed 34275403

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hodgkin Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Single-Arm, Open-label Study of Brentuximab Vedotin in Chinese Patients With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
ClinicalTrials.gov ID: NCT02939014
Acronym / sponsor ID: C25010
Conditions: Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic
Keywords: Drug therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 7 Nov 2016 (actual)
Primary completion: 2 Aug 2018 (actual)
Study completion: 3 Feb 2020 (actual)
First posted: 19 Oct 2016 (estimated)
Results: Posted 6 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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 1.8 mg/kg	Experimental	Drug: Brentuximab VedotinBrentuximab 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (19 listed)

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.

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 1.8 mg/kg

Primary outcome

Overall Response Rate (ORR)
Time frame: 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)
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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)
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.
Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events
Time frame: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)
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.
Number of Participants With Abnormal Vital Signs Reported as Adverse Events
Time frame: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)
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.

15 secondary outcomes

Complete Remission (CR) Rate
Time frame: 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)
Duration of Response (DOR)
Time frame: Up to 3.2 years
Progression Free Survival (PFS)
Time frame: Up to 3.2 years
Overall Survival (OS)
Time frame: Up to 3.2 years
B Symptom Resolution Rate
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)

Results and safety

Results posted to the registry on 6 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brentuximab Vedotin 1.8 mg/kg (HL)	30	25
Brentuximab Vedotin 1.8 mg/kg (sALCL)	9	6

Primary outcome: Overall Response Rate (ORR)

Time frame: 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 (95% Confidence Interval). Unit: percentage of participants

Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n = 30	Brentuximab Vedotin 1.8 mg/kg (sALCL) n = 9
Value	70.0 (50.60 to 85.27)	66.7 (29.93 to 92.51)

Population analysed: Modified Intent-to-Treat (mITT) Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months). Count of participants. Unit: Participants

Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n = 30	Brentuximab Vedotin 1.8 mg/kg (sALCL) n = 9
Value	30	9

Population analysed: Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

Primary outcome: Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events

Time frame: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months). Count of participants. Unit: Participants

Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n = 30	Brentuximab Vedotin 1.8 mg/kg (sALCL) n = 9
Alanine aminotransferase increased	18	6
Aspartate aminotransferase increased	17	6
Gamma-glutamyltransferase increased	3	4
Blood bilirubin increased	0	2
Reticulocyte count decreased	9	2
Reticulocyte count increased	6	1
Haemoglobin decreased	1	1
Reticulocyte percentage increased	1	0

Population analysed: Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

Primary outcome: Number of Participants With Abnormal Vital Signs Reported as Adverse Events

Time frame: First dose of study drug up to 30 days after last dose of study drug (approximately 12 months). Count of participants. Unit: Participants

Measure	Brentuximab Vedotin 1.8 mg/kg (HL) n = 30	Brentuximab Vedotin 1.8 mg/kg (sALCL) n = 9
Weight increased	4	2
Weight decreased	1	2

Population analysed: Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brentuximab Vedotin 1.8 mg/kg (HL)	1 of 30 (3.3%)	30 of 30 (100%)	4 of 30
Brentuximab Vedotin 1.8 mg/kg (sALCL)	1 of 9 (11.1%)	9 of 9 (100%)	3 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34275403Song 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.
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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Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis

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 Clinical Science study director

Takeda

7 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 in people with Hodgkin Disease and Lymphoma, Large-Cell, Anaplastic, run by Takeda at 7 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 12 inclusion and 19 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: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 6 Sep 2019). 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) (time frame: 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)). 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?

On the ClinicalTrials.gov record for NCT02939014, which also lists 1 linked publication.

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 24 Feb 2021.