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

A Phase 4, Single Arm, Open Label, Multicenter Study of Brentuximab Vedotin Treatment of Chinese Patients With CD30-Positive Cutaneous T-Cell Lymphoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: T-Cell Lymphoma
• Intervention / Treatment: Drug: Brentuximab vedotin

Detailed Description

The drug being tested in this study is called brentuximab vedotin (SGN-35). Brentuximab vedotin is being tested to treat people who have CD30-positive cutaneous T-Cell lymphoma.

The study will enroll approximately 10 patients. Participants will receive a single treatment i.e., brentuximab vedotin monotherapy:

• Brentuximab vedotin 1.8 mg/kg

Participants will be administered with brentuximab vedotin by intravenous (IV) infusion given for approximately 30 minutes on Day 1 of each 21-day cycle up to 16 cycles followed by the end of treatment (EOT) visit 30 days after receiving the final dose of study drug. Participants with progressive disease (PD) at any time during the study will be discontinued from study drug.

This multi-center trial will be conducted in China. Participants will remain in this study for approximately 56 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University first hospital
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital, Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically- confirmed cluster of differentiation antigen 30 positive (CD30+) disease by local laboratory assessment and pathology review.

2. 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.

6. Recovered (i.e., Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy.

-Exclusion Criteria:

1. A concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL), or other non-Hodgkin lymphoma (excluding lymphomatoid papulosis [LyP]).
2. A concurrent diagnosis of sézary syndrome (SS) or high blood tumor burden (B2) disease.
3. Corticosteroid therapy for the treatment of cutaneous T-cell lymphoma (CTCL) within 3 weeks of first dose of study drug.
4. Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
5. Life-threatening illness unrelated to cancer.
6. Severe central nervous system (CNS), pulmonary, renal, or hepatic disease not related to the participant's cancer.
7. Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
8. Known human immunodeficiency virus (HIV) positive.
9. Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
10. 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.)
11. Receiving antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.

12. 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.
13. History of another primary malignancy not in remission for at least 3 years. The following are exempt from the 3-year limit: completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear.
14. Oral retinoid therapy for any indication within 3 weeks of the first dose of study drug.
15. History of pancreatitis or significant risk factors for developing pancreatitis (eg, prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brentuximab Vedotin 1.8 mg/kg; Brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.	Drug: Brentuximab vedotin; Brentuximab vedotin IV infusion.; Other Names: SGN-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 will be 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 circulation Sezary cells. Response Criteria will be 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 (Olsen, 2011).	Up to 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) Rate	CR rate is defined as the percentage of participants with CR. CR is defined as complete disappearance of all clinical evidence of disease. CR will be determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using computed tomography (CT) scan, and for the participants with MF only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).	Up to 48 weeks
Overall Response Rate (ORR)	ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR will be determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using CT scan, and for the participants with MF only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).	Up to 48 weeks
Duration of Response (DOR)	Duration of response will be assessed in participants with CR or PR and is defined as the time between first documentation of response and PD. Response criteria will be based on ISCL, USCLC and EORTC Consensus guidelines (Olsen, 2011).	Up to 48 weeks
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An 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. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE and SAE will be determined as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.	From first dose of study drug through 30 days after the last dose of study drug (up to approximately 48 weeks)
Changes from Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure	Vital signs will include seated blood pressure (systolic and diastolic) measurements.	Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Changes from Baseline in Participant's Vital Sign: Heart Rate	Vital signs will include heart rate (beats per minute) measurements.	Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Changes from Baseline in Participant's Vital Sign: Body Temperature	Vital signs will include body temperature (degree celsius) measurements.	Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change From Baseline in Participant's Eastern Cooperative Oncology Group (ECOG) Performance Status Scale	ECOG scale will be used to assess performance status of participants. Grades range from 0 (fully active) to 5 (dead) where Grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed <50% of the time. Grade 3: In bed >50% of the time. Grade 4: 100% bedridden. Grade 5: Dead. Lower grades indicate improvement.	Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Hematology Parameter: Hemoglobin		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Hematology Parameter: Leukocyte with Differential Absolute Neutrophil Count (ANC)		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Hematology Parameter: Platelet Count		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP)		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT)		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST)		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Total Bilirubin		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen (BUN)		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Calcium		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Creatinine		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Lipase		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Chloride		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Gamma Glutamyl Transferase (GGT)		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Glucose		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Magnesium		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Phosphate		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Potassium		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Sodium		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Change from Baseline in Serum Chemistry Parameter: Amylase		Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immunoconjugates; Immunotoxins; Brentuximab Vedotin
• Other Study ID Numbers: C25029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No