A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib Versus Investigator's Choice in Adult Patients With Relapsed/Refractory Peripheral T-cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 218
- 试验地点
- 100
- 主要终点
- Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014
研究概览
简要总结
This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •The participants should sign the ICF and be able to comply with the relevant requirements in the ICF and protocol
- •Age ≥ 18 years
- •ECOG 0-2 score, life expectancy ≥ 12 weeks
- •Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classification of lymphoma. Eligible subtypes are restricted to: PTCL-not otherwise specified, NOS (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma ALK-positive (ALCL ALK+), anaplastic large-cell lymphoma ALK-negative (ALCL ALK-), Follicular T-cell lymphoma, or PTCL with T-follicular helper (TFH) phenotype (FTCL or PTCL-TFH), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Natural killer/T-cell lymphoma (NK/TCL), Hepatosplenic T-cell lymphoma (HSTCL), Subcutaneous panniculitis-like T-cell lymphoma (SPTCL)
- •Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator
- •Adequate bone marrow reserve and organ system functions
- •Willing to comply with contraceptive restrictions
排除标准
- •Any of previous or current treatment prohibited by protocol
- •Any unresolved > grade 2 drug-related adverse events
- •Lymphoma involving central nervous system
- •Any of severe cardiac or pulmonary abnormalities
- •Disease condition requires immunosuppressants, biologics, or NSAIDs
- •Active infection
- •Malignancy disease within five years
- •Poorly controlled gastrointestinal disorder or inadequate absorption of medication
- •Severe or poorly controlled systemic diseases
研究组 & 干预措施
Investigator's Choice
干预措施: Chidamide (Drug)
Investigator's Choice
干预措施: Gemcitabine (Drug)
Golidocitinib
干预措施: Golidocitinib (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014
时间窗: The time from the date of randomization to the date of first progressive disease, death due to any cause whichever occurred first. Approximately 4 years.
Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014
时间窗: The time from the date of randomization to the date of first progressive disease, death due to any cause whichever occurred first. Approximately 4 years.
次要结局
- Overall survival (OS)(The time from randomization to death due to any cause. Approximately 4 years.)