Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
研究概览
简要总结
The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lnclusion Criteria:
- •Male and female patients 20 to less than 80 years of age at the time of informed consent
- •Patients histologically or cytologically diagnosed to have peripheral T -cell lymphoma
- •Patients with a history of chemotherapy (including PUVA and retinoid) that resulted in relapse, recurrence and treatment resistance (just for the administration of E7777 alone)
- •Patients subject to CHOP therapy and without a history of prior treatment with anthracycline or anthraquinone anticancer drugs (just for the administration of E7777 in combination with CHOP therapy)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •No carry-over of beneficial or adverse effects of the prior treatment that may affect the safety evaluation of the investigational drug (excluding Grade 1 neuropathy and alopecia)
排除标准
- •Brain metastasis with clinical symptoms which requires treatment
- •Serious systemic infection requiring intensive treatment
- •Serious complications or histories
- •History of hypersensitivity to protein therapeutics
- •Known to be positive for HIV antibody, HCV antibody, or HBs antigen
- •History of malignancy other than peripheral T-cell lymphoma and less than five years have elapsed since the last remission
- •Patients who have undergone allogeneic hematopoietic stem cell transplantation
- •Patients with a relapse within 6 months after autologous hematopoietic stem-cell transplantation
研究组 & 干预措施
E7777
干预措施: denileukin diftitox (E7777) (Biological)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
时间窗: For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)
The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment.
次要结局
- Maximum Serum Concentration (Cmax) of Denileukin Diftitox(Cycle 1 (Day 1))
- Total Clearance (CL)(Cycle 1 (Day 1))
- Time to Cmax (Tmax) of Denileukin Diftitox in Serum(Cycle 1 (Day 1))
- Volume of Distribution at Terminal Phase (Vz)(Cycle 1 (Day 1))
- Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t))(Cycle 1 (Day 1))
- Recommended Dose(For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks))
- Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf))(Cycle 1 (Day 1))
- Terminal Phase Rate Constant (λz)(Cycle 1 (Day 1))
- Volume of Distribution at Steady State (Vss)(Cycle 1 (Day 1))
- Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox(From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months)
- Terminal Elimination Phase Half-life (t1/2)(Cycle 1 (Day 1))