Clinical trial · Interventional
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
NCT07641010CI-TRIAL-00114325not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 | Drug | — | UNRESOLVED |
| PD-1+JAK1i | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PD-1+JAK1i
- description
- PD-1+JAK1i (+AVD)
- interventionNames
- Drug: PD-1+JAK1i
- type
- ACTIVE_COMPARATOR
- label
- PD-1
- description
- PD-1 (+AVD)
- interventionNames
- Drug: PD-1
Primary outcomes (1)
- measure
- Complete Metabolic Response,CMR
- timeFrame
- Up to 7 weeks(After the end of the 1st cycle PD-1 ± JAKi treatment period)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.