A Phase II, Prospective, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Golidocitinib Combined With an Anthracycline-Based Regimen as First-Line Treatment for Patients With Nodal T-follicular Helper (TFH) Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) 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
- •Histologically confirmed nodal T-follicular helper (TFH) cell lymphoma according to the 2022 WHO classification.
- •Previously untreated with systemic anti-lymphoma therapy.
- •Age ≥18 and <75 years.
- •At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
- •An expected survival time of more than 12 weeks.
- •An ECOG performance status score of 0-
- •Adequate organ and bone marrow function.
- •Provision of written informed consent and willingness to comply with all study procedures.
排除标准
- •Hemophagocytic syndrome.
- •Central nervous system or meningeal involvement by lymphoma.
- •Patients with a history of other malignancies within the past 5 years or concurrent malignancies, except for basal cell carcinoma of the skin.
- •Patients receiving potent CYP3A inducers or inhibitors, vitamin K antagonists, antiplatelet agents, or anticoagulants.
- •Patients with active infections, including tuberculosis, HIV infection, active hepatitis B, or active hepatitis C.
- •Patients with severe or uncontrolled cardiovascular disease.
- •Patients with a history of interstitial lung disease, except for asymptomatic radiation-induced interstitial lung disease.
- •Patients with gastrointestinal conditions that may interfere with oral administration or drug absorption.
- •Patients with known hypersensitivity to golidocitinib or its excipients.
- •Pregnant or breastfeeding women and participants of childbearing potential unwilling to use effective contraception.
- •Patients who have received systemic corticosteroids or other immunosuppressive therapy within 14 days before the start of study treatment.
- •Patients considered unsuitable for participation by the investigator.
研究组 & 干预措施
Golidocitinib Combined with Doxorubicin/Epirubicin
Participants will receive golidocitinib 150 mg orally once daily in combination with either doxorubicin 50 mg/m² intravenously on Day 1 or epirubicin 60-90 mg/m² intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Participants who achieve a complete response (CR) or partial response (PR) may receive golidocitinib monotherapy as maintenance treatment for up to 12 months, as determined by the investigator.
干预措施: Doxorubicin (Drug)
Golidocitinib Combined with Doxorubicin/Epirubicin
Participants will receive golidocitinib 150 mg orally once daily in combination with either doxorubicin 50 mg/m² intravenously on Day 1 or epirubicin 60-90 mg/m² intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Participants who achieve a complete response (CR) or partial response (PR) may receive golidocitinib monotherapy as maintenance treatment for up to 12 months, as determined by the investigator.
干预措施: Golidocitinib (Drug)
Golidocitinib Combined with Doxorubicin/Epirubicin
Participants will receive golidocitinib 150 mg orally once daily in combination with either doxorubicin 50 mg/m² intravenously on Day 1 or epirubicin 60-90 mg/m² intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Participants who achieve a complete response (CR) or partial response (PR) may receive golidocitinib monotherapy as maintenance treatment for up to 12 months, as determined by the investigator.
干预措施: Epirubicin (Drug)
结局指标
主要结局
Complete response rate
时间窗: Up to 6 cycles (each cycle is 21 days)
Defined as the proportion of patients who achieve complete remission at the end of induction treatment.
次要结局
- Progression-free survival(PFS)(From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- Overall survival(OS)(From the date of enrollment until the date of death from ant cause, assessed up to 24 months)
- Objective response rate (ORR)(Up to 6 cycles (each cycle is 21 days))
- Duration of Response(DOR)(The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months)
- Adverse events(Up to 28 days after the last dose of study treatment)
研究者
Qingqing Cai
Principal Investigator
Sun Yat-sen University