A Single Arm, Multi-center, Phase Ib Clinical Trial of PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Parsaclisib in Combination with Chidamide
研究概览
简要总结
This is a prospective single-arm, multicenter, phase Ib clinical trial of PI3Kδ inhibitor Parsaclisib combined with chidamide for the treatment of relapsed/refractory 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 75 years old (including 18 and 75)
- •Agreeing to sign the written informed consents
- •Diagnosed as peripheral T-cell lymphoma, including peripheral T-cell lymphoma, unspecified type, anaplastic large cell lymphoma (ALK negative or positive), angioimmunoblastic T-cell lymphoma, enteropathy Related T-cell lymphoma, hepatosplenic T-cell lymphoma, γ/δ T-cell lymphoma, NK/T-cell lymphoma, and other subtypes of PTCL that the investigator judges to be suitable for participating in this study
- •Received at least first-line anti-tumor therapy in the past, whether or not Chidamide has been used
- •Having at least one measurable lesions
- •World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
- •Life expectancy no less than 3 months
- •enough main organ function
- •Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- •Agreeing to follow the trail protocol requirements
排除标准
- •Types other than peripheral T-cell lymphoma listed in the enrollment criteria
- •Diagnosed as central nervous system lymphoma
- •Received palliative treatment for other malignant tumors in the past 2 years
- •Uncontrolled active infection
- •Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- •The non-hematological toxicity caused by the previous anti-tumor treatment has not recovered to ≤1 grade, and the hematological toxicity has not recovered to ≤2 grade
- •Patients with a history of mental illness
- •Those who are known to be allergic to the active ingredients or excipients of the drug parsaclisib and chidamide
- •Received PI3Kδ inhibitor treatment in the past
- •Received autologous hematopoietic or allogeneic hematopoietic stem cell transplantation within 3 months
- •World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) >2
- •There are factors that affect the absorption of oral drugs
- •Pregnant or lactating women
- •Researchers determine unsuited to participate in this trial
研究组 & 干预措施
PI3Kδ inhibitor Parsaclisib plus Chidamide
Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day.
Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast.
干预措施: Parsaclisib (Drug)
PI3Kδ inhibitor Parsaclisib plus Chidamide
Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day.
Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast.
干预措施: Chidamide (Drug)
结局指标
主要结局
Safety and Tolerability of Parsaclisib in Combination with Chidamide
时间窗: Approximately 2 years
This outcome measure will evaluate the safety and tolerability of parsaclisib when administered in combination with chidamide. Safety will be assessed by monitoring adverse events (AEs), dose-limiting toxicities (DLTs), and other clinically significant toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE). Tolerability will be assessed based on the occurrence and severity of AEs during the trial, as well as the ability of patients to complete the treatment regimen without discontinuation due to adverse effects.
Recommended Phase 2 Dose (RP2D) of Parsaclisib in Combination with Chidamide
时间窗: Approximately 2 years
This outcome measure will determine the recommended Phase 2 dose (RP2D) of parsaclisib when combined with a fixed dose of 20 mg of chidamide administered twice weekly (BIW). The RP2D will be determined based on dose escalation, safety data, and the tolerability observed in the Phase Ib portion of the study. The RP2D will be the highest dose level at which no more than 33% of patients experience dose-limiting toxicities (DLTs) within the first treatment cycle.
次要结局
- Objective Response Rate (ORR)(Through study completion, approximately 2 years)
- Complete Response Rate (CRR)(Through study completion, approximately 2 years)
- 1-year progression-free survival(from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 28 days).)
- 1-year overall survival(from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years after last patient's enrollment (each cycle is 28 days).)
研究者
Yanyan Liu
Director
Henan Cancer Hospital