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

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

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

Primary outcomes

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

Sex: All, ages: 6 Years to 18 Years

Inclusion Criteria:

1. Age 6-18 years, male or female;
2. Histologically confirmed classic Hodgkin lymphoma;
3. Newly diagnosed, previously untreated patients;
4. 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;
5. ECOG performance status (PS) 0-2;
6. Life expectancy ≥3 months;
7. 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:
8. 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;
9. 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;
10. The patient or his/her legal guardian has signed the informed consent form (ICF) and voluntarily agrees to participate in this study.

Exclusion Criteria:

1. Histopathologically confirmed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL);
2. Prior anti-tumor therapy for classic Hodgkin lymphoma (cHL);
3. Patients with central nervous system (CNS) involvement by lymphoma;
4. Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption;
5. 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);
6. 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);
7. History of other malignancies within the past 5 years;
8. Severe cardiac dysfunction with ejection fraction (EF) <50%, or severe cardiac arrhythmia;
9. Any arterial thromboembolic event within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;
10. Active hepatitis B or hepatitis C infection;
11. History of stroke or intracranial hemorrhage within the past 6 months;
12. Known history of human immunodeficiency virus (HIV) positivity.