NCT07180771尚未招募2 期
A Phase II, Single-arm, Multicenter, Open Label Study to Evaluate Efficacy and Safety of BR101801 Monotherapy in Relapsed/Refractory Peripheral T-cell Lymphoma Patients
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
研究概览
简要总结
The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
详细描述
This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ECOG performance status ≤
- •Life expectancy more than 3 months.
- •Patients with relapsed and/or refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification
- •Peripheral T-cell lymphoma, not otherwise specified
- •Nodal TFH cell lymphoma, angioimmunoblastic-type
- •Nodal TFH cell lymphoma, follicular-type
- •Nodal TFH cell lymphoma, NOS
- •Patients currently requiring systemic therapy at the investigator's discretion.
- •Patients with a lesion measuring 1.5 cm or more in its longest transverse diameter, as determined by CT, PET/CT or MRI scans according to the 2014 Lugano criteria.
排除标准
- •The presence of overt leptomeningeal or active central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks.
- •Impaired cardiac function or clinically significant cardiac disease.
- •Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.
- •For patients with lymphoma:
- •Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon [INF], and toxin immunoconjugates) or any experimental therapy within 3 weeks or 5 half lives, whichever is shorter, before the first dose of study treatment.
- •Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
- •Unconjugated monoclonal antibody therapies < 6 weeks before the first dose of study treatment.
- •Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (>20 mg/day prednisone or equivalent).
研究组 & 干预措施
BR101801 (Bosmolisib)
Experimental
Patients will receive BR101801 capsules orally, QD in 28-day cycles
干预措施: BR101801 (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
时间窗: Up to 2 years
次要结局
- Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Progression-free Survival (PFS)(Up to 2 years)
- Time to Tumor Progression (TTP)(Up to 2 years)
- Quality of life assessment Using the EQ-5D-5L assessment(Every 2 cycles for up to 24 months (each cycle is 28 days))
- Quality of life assessment Using EORTC QLQ-C30 assessment(Every 2 cycles for up to 24 months (each cycle is 28 days))
- Plasma Concentration of BR101801 (Bosmolisib)(Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days))
- Adverse events(Approximately 24 months after a consent to the participation)
研究者
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