A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma

NCT05442554 | Completed Phase 4 Results

• 1 other identifier: C25029
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

The main aim is to check the long-term side effects of treatment with Brentuximab Vedotin and to see if that treatment improves symptoms of cluster of differentiation antigen 30 (CD30-Positive) Cutaneous T-Cell Lymphoma in Chinese adults. Participants will receive brentuximab vedotin through the vein on day 1 of each 21 day cycle up to maximum 16 cycles.

Conditions

T-Cell Lymphoma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL

  ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) that lasts at least 4 months. CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral involvement using computed tomography (CT) scan, and for the participants with mycosis fungoides (MF) only, detection of circulating Sezary cells. Response Criteria were based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines.

  Up to 58 weeks

Secondary Outcomes (19)

• Complete Response (CR) Rate

  Up to 58 weeks

• Overall Response Rate (ORR)

  Up to 58 weeks

• Duration of Response (DOR)

  Up to 58 weeks

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From first dose of study drug through 30 days after the last dose of study drug (up to approximately 58 weeks)

• Changes From Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure

  Baseline, at end of treatment (approximately Week 54)

Study Arms (1)

Brentuximab Vedotin

EXPERIMENTAL

Participants received brentuximab vedotin 1.8 milligrams per kilogram (mg/kg), IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.

Drug: Brentuximab vedotin

Interventions

Brentuximab vedotin DRUG

Brentuximab vedotin IV infusion.

Also known as: SGN-35

Brentuximab Vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically- confirmed cluster of differentiation antigen 30 positive (CD30+) disease by local laboratory assessment and pathology review.
• \. Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) who have received prior radiation therapy or at least 1 prior systemic therapy, or participants with mycosis fungoides (MF) who have received at least 1 prior systemic therapy for their disease. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 4. Suitable venous access for the study-required blood sampling. 5. Participants must have radiographically or clinically measurable or evaluable disease.
• \. Recovered (i.e., Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy.

You may not qualify if:

• A concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL), or other non-Hodgkin lymphoma (excluding lymphomatoid papulosis \[LyP\]).
• A concurrent diagnosis of sézary syndrome (SS) or high blood tumor burden (B2) disease.
• Corticosteroid therapy for the treatment of cutaneous T-cell lymphoma (CTCL) within 3 weeks of first dose of study drug.
• Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
• Life-threatening illness unrelated to cancer.
• Severe central nervous system (CNS), pulmonary, renal, or hepatic disease not related to the participant's cancer.
• Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
• Known human immunodeficiency virus (HIV) positive.
• Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
• Any severe active systemic viral, bacterial, or fungal infection within 1 week before first study drug dose requiring systemic antimicrobial therapy. (Oral antibiotics for prophylaxis are allowed.)
• Receiving antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.
• Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
• Myocardial infarction within 6 months of enrollment.
• New York Heart Association (NYHA) Class III or IV heart failure.
• Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Links

• To obtain more information about this study, click this link.

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 5, 2022
• Study Start: November 28, 2022
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: September 18, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)