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Clinical Trials in China / NCT07641010
Starting soon Phase 1/2

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

NCT07641010 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Jiao Tong University School of Medicine
Phase
Phase 1/2
Started
2026-06-30
Last updated
2026-06-11

Condition(s) studied

Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

PD-1+JAK1iPD-1

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

PD-1: PD-1 inhibitor: 3 mg/kg, IV, D1, 22;

Study summary

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

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuzhou Children's Hospital Xuzhou Jiangsu

More Shanghai Jiao Tong University School of Medicine trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07641010 on ClinicalTrials.gov ↗ ← All trials in China