A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 40
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride [hydroxydaunorubicin], vincristine sulfate [Oncovin], and prednisone [CHOP] or equivalent multiagent chemotherapy regimens with curative intent).
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
- •Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
- •Bidimensional measurable disease
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence
- •Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence
- •Clinical laboratory values as specified in the study protocol
排除标准
- •Previous treatment with brentuximab vedotin.
- •Previously received an allogeneic transplant.
- •Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).
- •Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
- •Female participants who are lactating and breastfeeding or pregnant
- •Known human immunodeficiency virus (HIV) positive
- •Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
研究组 & 干预措施
Brentuximab Vedotin 1.8 mg/kg
Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
干预措施: Brentuximab vedotin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)
ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
次要结局
- Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody(Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion)
- Duration of Response (DOR) Per IRF(Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years))
- Progression-free Survival (PFS) Per IRF(Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years))
- Complete Remission Rate (CRR) Per IRF(Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years))
- Overall Survival (OS)(Until disease progression, death, or end of study (Up to approximately 10.7 years))
- Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin(Until disease progression, death, or end of study (Up to approximately 10.7 years))
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)(From first dose up to 30 days post last dose of study drug (Up to approximately 1 year))
- Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion(Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion)
- Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE)(Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion)
- Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin(Up to 16 cycles (each cycle = 21 days))