A Phase 4, Single Arm, Open Label, Multicenter Study of Brentuximab Vedotin Treatment of Chinese Patients With CD30-Positive Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Suitable venous access for the study-required blood sampling.
- •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.
排除标准
- •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.
- •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.
- •Oral retinoid therapy for any indication within 3 weeks of the first dose of study drug.
- •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).
研究组 & 干预措施
Brentuximab Vedotin
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.
干预措施: Brentuximab vedotin (Drug)
结局指标
主要结局
Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL
时间窗: Up to 58 weeks
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.
次要结局
- 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))
- Changes From Baseline in Participant's Vital Sign: Heart Rate(Baseline, at end of treatment (approximately Week 54))
- Changes From Baseline in Participant's Vital Sign: Body Temperature(Baseline, at end of treatment (approximately Week 54))
- Number of Participants From Baseline to Worst Post-Baseline Assessment Categories Based on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale(Baseline up to 30 days after the last dose of study drug (up to approximately 58 weeks))
- Change From Baseline in Hematology Parameter: Hemoglobin(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Hematology Parameter: Neutrophil Count(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Hematology Parameter: Platelet Count(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Hematology Parameter: Lymphocyte Count(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Hematology Parameter: Leukocyte Count(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP)(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT)(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST)(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Serum Chemistry Parameter: Total Bilirubin(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Serum Chemistry Parameter: Lipase(Baseline, at end of treatment (approximately Week 54))
- Change From Baseline in Serum Chemistry Parameter: Amylase(Baseline, at end of treatment (approximately Week 54))