Clinical trial NCT05442554: A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma
Official title: A Phase 4, Single Arm, Open Label, Multicenter Study of Brentuximab Vedotin Treatment of Chinese Patients With CD30-Positive Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: T-Cell Lymphoma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Complete Response (CR) Rate
timeFrame: Up to 48 weeks
measure: Overall Response Rate (ORR)
timeFrame: Up to 48 weeks
measure: Duration of Response (DOR)
timeFrame: Up to 48 weeks
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study drug through 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Changes from Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Changes from Baseline in Participant's Vital Sign: Heart Rate
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Changes from Baseline in Participant's Vital Sign: Body Temperature
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change From Baseline in Participant's Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Hematology Parameter: Hemoglobin
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Hematology Parameter: Leukocyte with Differential Absolute Neutrophil Count (ANC)
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Hematology Parameter: Platelet Count
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP)
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT)
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST)
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Total Bilirubin
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen (BUN)
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Calcium
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Creatinine
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Lipase
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Chloride
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Gamma Glutamyl Transferase (GGT)
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Glucose
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Magnesium
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Phosphate
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Potassium
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Sodium
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
measure: Change from Baseline in Serum Chemistry Parameter: Amylase
timeFrame: Baseline up to 30 days after the last dose of study drug (up to approximately 48 weeks)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: