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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hodgkin Lymphoma
• Intervention / Treatment: Drug: PD-1+JAK1i; Drug: PD-1

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shuhong Shen; Phone Number: +86 18930830638; Email: shenshuhong@scmc.com.cn

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • Xuzhou Children's Hospital
      • Contact: Shuhong Shen; Phone Number: +86 18930830638; Email: shenshuhong@scmc.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD-1+JAK1i; PD-1+JAK1i (+AVD)	Drug: PD-1+JAK1i; PD-1 inhibitor: 3 mg/kg, IV, D1, 22; JAK1i: 4mg/m2, PO, QD, D1-35;
Active Comparator: PD-1; PD-1 (+AVD)	Drug: PD-1; PD-1 inhibitor: 3 mg/kg, IV, D1, 22;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete Metabolic Response，CMR	Up to 7 weeks（After the end of the 1st cycle PD-1 ± JAKi treatment period）

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hemic and Lymphatic Diseases; Hodgkin Disease
• Other Study ID Numbers: MA-HL-II-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No