A Single-arm, Open-label, Phase II Study of Golidocitinib and Benmelstobart Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (JACKPOT50)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects fully understand and voluntarily participate in this study and sign informed consent.
- •Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
- •Age ≥18, no gender limitation.
- •Treatment failure to at least one line of asparaginase-based therapy.
- •Eastern Cooperative Oncology Group performance status of 0-2
- •Expected survival ≥ 3 months.
- •At least one measurable lesion that meets Lugano 2014 criteria.
- •Sufficient organ function.
排除标准
- •Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.
- •Accompanied by hemophagocytic lymphohistiocytosis.
- •NKTCL with central nervous system invasion.
- •Previously treated with JAK inhibitors.
- •The patients have contraindications to any drug in the combined treatment.
- •Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- •Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
- •Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
- •Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.
研究组 & 干预措施
Golidocitinib and Benmelstobart Combination
Patients will receive golidocitinib in combination with benmelstobart every 3 weeks for up to 24 months, until disease progression, unaccpetable toxicities or other reasons lead to discontinuation.
干预措施: Golidocitinib (Drug)
Golidocitinib and Benmelstobart Combination
Patients will receive golidocitinib in combination with benmelstobart every 3 weeks for up to 24 months, until disease progression, unaccpetable toxicities or other reasons lead to discontinuation.
干预措施: Benmelstobart (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: 2 years
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
次要结局
- Complete Response(CR)(2 years)
- Duration of Response(DOR)(Up to 4 years)
- Progression-free survival(PFS)(Up to 4 years)
- Overall survival(OS)(Up to 4 years)
- Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE)(Through study completion, up tp 2 years.)
研究者
Qingqing Cai
MD. PhD.
Sun Yat-sen University