A Prospective Single-Center Phase I/II Clinical Study of Golidocitinib Combined With Chidamide in Patients With Systemically-Treated Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Recommended Phase II Dose (RP2D)
研究概览
简要总结
This is a prospective, single-center phase I/II study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. The primary endpoint of the phase I study was to determine the recommended phase II dose (RP2D), while the primary endpoint of the phase II study was the objective response rate (ORR). Secondary endpoints included the complete response (CR) rate, progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety profile.
详细描述
of golidocitinib in combination with chidamide and to determine the recommended phase II dose (RP2D). The study follows a standard "3+3" design. The starting dose of golidocitinib is 150 mg every other day, with pre-specified dose levels including 150 mg every other day and 150 mg once daily. Chidamide is administered at a fixed dose of 20 mg twice weekly. In the phase II segment (dose expansion phase), all participants will receive the combination therapy of golidocitinib and chidamide. Golidocitinib will be administered at the RP2D established in the phase I study, while chidamide will continue at the fixed dose of 20 mg twice weekly. Each treatment cycle is defined as 4 weeks. Tumor response will be assessed every 3 treatment cycles, and safety evaluations will be performed every cycle.
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
- •Histopathologically confirmed cutaneous T-cell lymphoma.
- •Patients with measurable disease, with or without extracutaneous lesions, and clinical stage IB-IVB.
- •Disease that has not responded to or has relapsed after at least one prior systemic therapy (including, but not limited to, total skin electron beam therapy, bexarotene, retinoids, interferon, extracorporeal photopheresis, methotrexate, or chidamide).
- •An ECOG performance status of 0 to
- •Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L, Platelet count (PLT) ≥80×10⁹/L, Hemoglobin (HGB) ≥90 g/L.
- •Adequate organ function: Cardiac function Class 1-2 (NYHA), Left Ventricular Ejection Fraction (LVEF) ≥50%, Alanine Aminotransferase (ALT) < 2.5 × Upper Limit of Normal (ULN), Total Bilirubin (TBil) < 1.5 × ULN, Oxygen Saturation (SpO₂) > 93% on Room Air, estimated Glomerular Filtration Rate (eGFR) based on serum creatinine (sCr) > 60 mL/min/1.73m².
排除标准
- •Acute myocardial infarction, unstable angina, congestive heart failure, symptomatic arrhythmia within the past 6 months, or significant QT interval prolongation (corrected QT interval >450 ms in males or >470 ms in females).
- •Uncontrolled active infection.
- •Active tuberculosis infection.
- •Active Hepatitis B (HBV DNA > 1×10³ copies/mL) or Hepatitis C (HCV RNA > 1×10³ copies/mL) infection.
- •Pregnancy or lactation.
- •Any other condition deemed by the investigator as unsuitable for participation in this study.
研究组 & 干预措施
Golidocitinib and Chidamide
The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study. Chidamide is administered at a fixed dose of 20 mg twice weekly.
干预措施: golidocitinib (Drug)
Golidocitinib and Chidamide
The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study. Chidamide is administered at a fixed dose of 20 mg twice weekly.
干预措施: Chidamide (Drug)
结局指标
主要结局
Recommended Phase II Dose (RP2D)
时间窗: From enrollment to the end of treatment at 4 weeks
The RP2D is determined based on the occurrence of dose-limiting toxicities (DLTs) during the first cycle (28 days) of treatment. It is defined as the highest dose level at which fewer than 33% of participants experience a DLT.
Objective Response Rate (ORR)
时间窗: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR).
次要结局
- Complete Response (CR) Rate(From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause)
- Progression-Free Survival (PFS)(From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause)
- Overall Survival (OS)(From enrollment to the end of 2-year follow-up phase or death from any cause)
研究者
Wei Zhang
Prof.
Peking Union Medical College Hospital