NCT05978739已完成2 期
A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma
InnoCare Pharma Inc.21 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 21
- 主要终点
- Objective response rate（ORR）
研究概览
简要总结
This is A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma to Evaluate the Efficacy and Safety in Mantle Cell Lymphoma.
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
- •Male and female subjects ≥ 18 years of age.
- •Mantle cell lymphoma (MCL) confirmed by histopathology.
- •Subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care.
- •At least one measurable lesion.
- •ECOG Physical fitness score 0-2 points.
- •Expected survival time ≥ 4 months.
- •Full hematology function.
- •Blood clotting function is basically normal.
- •Subjects with basically normal liver, kidney and heart function.
- •Subject voluntarily signs a written ICF.
- •The serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing.
- •Female subjects with reproductive potential or male subjects and their partners must agree to use effective contraception for at least 6 months from signing the ICF until the last dose of the study drug.
排除标准
- •Adequate treatment with BTK inhibitors.
- •Have a history of severe allergic disease and a history of severe drug allergy.
- •Subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug.
- •The last use of a potent CYP3A inhibitor or potent CYP3A inducer (including food, western medicine, and Chinese medicine) was less than 2 weeks (or less than 5 half-lives, depending on the time) from the first trial, or plan to take a potent CYP3A inhibitor or potent CYP3A inducer drug or food during the study period.
- •History of other active malignant diseases within 2 years prior to screening.
- •Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity.
- •Indicates active hepatitis B or C virus infection.
- •There are diseases that are excluded from the criteria in the programme.
- •Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study therapy (according to CTCAE V5.0).
- •History of severe bleeding disorder.
- •People with a known history of alcohol or drug abuse.
- •Subjects with mental disorders or poor compliance.
- •Pregnant or lactating female subjects.
- •Other conditions deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
Orelabrutinib low dose
Experimental
干预措施: Orelabrutinib Low dose (Drug)
Orelabrutinib high dose
Experimental
干预措施: Orelabrutinib High dose (Drug)
结局指标
主要结局
Objective response rate（ORR）
时间窗: Through study completion, an average of 2 year
Proportion of subjects with tumor response of Complete Response（CR） or Partial Response（PR） after treatment in total subjects.
次要结局
- Complete Response Rate （CRR）(Through study completion, an average of 2 year)
- Duration of Response (DoR)(Through study completion, an average of 2 year)
- Maximum concentration (Cmax,ss)(Predose up to 24 hours postdose)
- Adverse events（AEs）(Through study completion, an average of 2 year)
- Progression-Free Survival (PFS)(Through study completion, an average of 2 year)
- Half-life (T1/2)(Predose up to 24 hours postdose)
- Time to maximum concentration (Tmax)(Predose up to 24 hours postdose)
- Area under the plasma concentration-time curve (AUC)(Predose up to 24 hours postdose)
- Apparent clearance (CL/F)(Predose up to 24 hours postdose)
- Serious adverse events （SAEs）(Through study completion, an average of 2 year)
研究者
研究点 (21)
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