An Open-label, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib Combined With Azacitidine and Chidamide in Patients With Peripheral T-cell Lymphoma.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Overall Response Rate
研究概览
简要总结
In decades, the outcome of patients with peripherial T-cell lymphomas is dismal, especially in relapsed or refractory population. After failure to the frontline treatment, patients have limited treatment options and elderly population usually have no chance to undergo transplantation due to age or comorbidity, etc. Golidocitinib and chidamide were approved in treating r/r PTCL in China, while azacytidine has been demonstrated its anti-tumor activity in PTCL as well.
This study aims to explore the efficacy and safety of golidocitinib combined with azacytidine and chidamide in the patients with peripheral T-cell lymphoma who are eligible for intensive chemotherapy or transplantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed peripheral T-cell lymphoma;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;
- •Expected survival of ≥12 weeks;
- •Measurable disease lesions;
- •Any conditions considered ineligible for intenvive chemotherapy, including but not limted to age > 60 years, at least one comorbidity scored 3 points, or more than 4 comorbidities scored 2 points each according to the CIRS scale;
- •Female participants of childbearing potential and male participants with partners of childbearing potential must agree to and adhere to effective contraceptive measures during the treatment period and for 180 days after the last dose of the study drug;
- •Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up assessments.
排除标准
- •Involvement of the central nervous system (CNS);
- •History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
- •Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- •Left ventricular ejection fraction<50%
- •Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
- •Neutrophils<1.5×10^9/L
- •Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
- •ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
- •Creatinine is 1.5 times higher than the ULN.
- •HIV-infected patients
- •Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
- •Pregnant or lactation
- •Require treatment with strong/moderate CYP3A inhibitors or inducers.
- •Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
- •Other medical conditions determined by the researchers that may affect the study
研究组 & 干预措施
golidocitinib with azacytidine and chidamide
干预措施: golidocitinib with azacytidine and chidamide (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year
Percentage of participants with complete response or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria
次要结局
- Progression-free survival(Baseline up to data cut-off(up to approximately 3 years))
- Complete Response Rate(Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year.)
- Duration of Response(Baseline up to data cut-off(up to approximately 3 years))
- Overall survival(Baseline up to data cut-off(up to approximately 3 years))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0(From enrollment to study completion, a maximum of 4 years)
研究者
Zhao Weili
Professor and Director，Shanghai Institute of Hematology
Ruijin Hospital