NCT07641010尚未招募1 期
A Prospective, Multicenter, Randomized Controlled Clinical Study of Camrelizumab in Combination With Ivarmacitinib as First-line Treatment for Pediatric Classical Hodgkin Lymphoma
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2026年6月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
研究概览
简要总结
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
详细描述
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-18 years, male or female;
- •Histologically confirmed classic Hodgkin lymphoma;
- •Newly diagnosed, previously untreated patients;
- •Subjects must have at least one measurable lesion, defined as: a lymph node lesion with the longest diameter >1.5 cm on CT cross-sectional imaging; or an extranodal lesion with the longest diameter >1.0 cm;
- •ECOG performance status (PS) 0-2;
- •Life expectancy ≥3 months;
- •All screening laboratory tests must be performed as required by the protocol and within 7 days prior to enrollment. The laboratory values obtained at screening must meet the following criteria:
- •Hematology (without blood transfusion, G-CSF, or medication to correct abnormalities within 14 days prior to screening):
- •Hemoglobin (Hb) ≥70 g/L;
- •Absolute neutrophil count (ANC) ≥0.5×10⁹/L;
- •Platelet count (PLT) ≥30×10⁹/L;
- •Biochemistry:
- •Direct bilirubin (DBIL) <2 × upper limit of normal (ULN);
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN;
- •Serum creatinine clearance ≥40 mL/min;
- •The patient or his/her legal guardian has signed the informed consent form (ICF) and voluntarily agrees to participate in this study.
排除标准
- •Histopathologically confirmed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL);
- •Prior anti-tumor therapy for classic Hodgkin lymphoma (cHL);
- •Patients with central nervous system (CNS) involvement by lymphoma;
- •Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption;
- •Presence of any active, known, or suspected autoimmune disease (subjects who are in a stable condition and do not require systemic immunosuppressive therapy are permitted to enroll);
- •Use of immunosuppressive agents, including systemic corticosteroids, within 14 days prior to study drug administration (use of ≤10 mg/day prednisone or equivalent is permitted);
- •History of other malignancies within the past 5 years;
- •Severe cardiac dysfunction with ejection fraction (EF) <50%, or severe cardiac arrhythmia;
- •Any arterial thromboembolic event within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;
- •Active hepatitis B or hepatitis C infection;
- •History of stroke or intracranial hemorrhage within the past 6 months;
- •Known history of human immunodeficiency virus (HIV) positivity.
研究者
Shuhong Shen
Chair of hematology oncology department of SCMC
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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