A Phase I/II Study of Golidocitinib in Combination with CHOP in Patients with Newly Diagnosed Peripheral T Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Recommended phase 2 dose (RP2D) of phase 1 study
研究概览
简要总结
This is single-arm phase I/II study designed to evaluate the safety and efficacy of golcadotinib in combination with the CHOP regimen for patients with newly diagnosed peripheral T-cell lymphoma (PTCL). The study adopts a two-stage design, consisting of a Phase I and a Phase II parts. In the phase I study, a standard "3+3" design will be used. The primary endpoints of the Phase I study are the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). The primary endpoint of the Phase II study is the complete response rate (CRR) of the golcadotinib combined with CHOP regimen.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years;
- •Histopathologically confirmed diagnosis of PTCL of one of the following subtypes: (1) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); (2) Angioimmunoblastic T-cell lymphoma (AITL); (3) Anaplastic large cell lymphoma (ALCL); or (4) other PTCL subtypes considered eligible by the investigator;
- •Patients must have at least one measurable lesion according to the Lugano 2014 criteria: For lymph node lesions, the measurable lymph node must have a long diameter >1.5 cm; for non-lymph node lesions, the measurable extranodal lesion must have a long diameter >1.0 cm;
- •ECOG performance status score of 0-3;
- •Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count (PLT) ≥75×10^9/L, and hemoglobin (HGB) ≥90 g/L (for patients with bone marrow involvement, ANC can be relaxed to ≥1.0×10^9/L, PLT to ≥50×10^9/L, and HGB to ≥75 g/L);
- •Adequate organ function: alanine aminotransferase (ALT) <3 times the upper limit of normal (ULN), total serum bilirubin (TBIL) ≤1.5 times ULN, creatinine clearance ≥50 mL/min, and left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiography.
排除标准
- •Extranodal NK/T-cell lymphoma;
- •History of acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmias, or significant QT interval prolongation (men >450 ms, women >470 ms) within the past 6 months;
- •Uncontrolled active infection;
- •ANC ≤0.5×10^9/L, lymphocyte count ≤0.4×10^9/L, PLT ≤75×10^9/L, ALT ≥3 times the ULN, or creatinine clearance ≤50 mL/min;
- •Presence of primary or secondary central nervous system (CNS) lymphoma at the time of enrollment;
- •Pregnant or breastfeeding women;
- •Patients who have received any investigational drug or radiotherapy within the past 4 weeks;
- •Individuals deemed unsuitable for participation by the investigator;
研究组 & 干预措施
G-CHOP arm
干预措施: Golidocitinib plus CHOP (Drug)
结局指标
主要结局
Recommended phase 2 dose (RP2D) of phase 1 study
时间窗: 4 weeks since the date of first dose]
Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of golidocitinib
complete remission rate (CRR) of the phase 2 study
时间窗: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)
Treatment responses were assessed according to the 2014 Lugano classification criteria.
次要结局
- Progression-free survival(From date of enrollment until documented disease progression or death of any reason (up to 3 years))
- Overall survival(From date of enrollment until documented death of any reason (up to 3 years))
- adverse events(From enrollment till 28 days post the last induction cycle)
- Objective Response Rate (ORR)(Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days))