PD-1 Antibody and JAK1 Inhibitor for Newly Diagnosed Pediatric Hodgikin's Lympoma

Официальное название

A Prospective, Multicenter, Randomized Controlled Clinical Study of Camrelizumab in Combination With Ivarmacitinib as First-line Treatment for Pediatric Classical Hodgkin Lymphoma

Обзор

A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma

Подробное описание

A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma

Вмешательства

• Препарат PD-1+JAK1i
  PD-1 inhibitor: 3 mg/kg, IV, D1, 22; JAK1i: 4mg/m2, PO, QD, D1-35;
• Препарат PD-1
  PD-1 inhibitor: 3 mg/kg, IV, D1, 22;

Первичные конечные точки

• Complete Metabolic Response，CMR [Срок оценки: Up to 7 weeks（After the end of the 1st cycle PD-1 ± JAKi treatment period）]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuzhou Children's Hospital — Xuzhou

Идентификаторы

NCT: NCT07641010 · MA-HL-II-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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