Hodgkin Lymphoma
Conditions
Brief summary
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
Detailed description
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
Interventions
DRUGPD-1+JAK1i
PD-1 inhibitor: 3 mg/kg, IV, D1, 22; JAK1i: 4mg/m2, PO, QD, D1-35;
DRUGPD-1
PD-1 inhibitor: 3 mg/kg, IV, D1, 22;
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Metabolic Response，CMR | Up to 7 weeks（After the end of the 1st cycle PD-1 ± JAKi treatment period） |
Countries
China
Contacts
CONTACTShuhong Shen
Outcome results
None listed