JPRN-jRCT2080223116已完成2 期
A Phase 2 study of E7777 in patients with relapsed or refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
研究概览
简要总结
The ORR was 36.1% in the Full Analysis Set by the independent review, indicating clinically meaningful efficacy in patients with relapsed or refractory PTCL and CTCL. Although TEAEs including hepatobiliary disorders, hematological toxicity, capillary leak syndrome, and rhabdomyolysis were observed in this study, the safety profile of E7777 has been shown to be acceptable and manageable with careful monitoring of those toxicities in patients with relapsed or refractory PTCL and CTCL.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
- •2.Participant who have measurable disease.
- •3.Participant who had previous systemic chemotherapy.
- •4.Participant who had disease progression (PD) or did not have response (complete response (CR) or partial response (PR)) in systemic chemotherapy, or relapsed or progressed after systemic chemotherapy.
- •5.Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- •6.Participant with adequate renal, liver and bone marrow function.
- •7.Male and female participants ≥20 years of age at the time of informed consent.
- •8.Participants who have provided written consent to participate in the study.
排除标准
- •1.Participant with serious complications or histories.
- •2.Participant with history of hypersensitivity to protein therapeutics.
- •3.Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.
- •4.Participant with malignancy of activity other than PTCL or CTCL within 36 months before informed consent.
- •5.Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception.
- •6.Woman who is pregnant or lactating.
- •7.Participant with allogeneic stem cell transplantation.
- •8.Participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.
研究者
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