Sintilimab Plus AVD in Pediatric Low/Moderate Risk Hodgkin Lymphoma: A Phase II Study

Exclusion Criteria

• •1. History of solid organ transplantation at any time or allogeneic hematopoietic stem cell transplantation within the past 5 years.
• •2. Female participants with reproductive potential who test positive for pregnancy on a urine pregnancy test within 24 hours before the first dose.
• •3. Baseline left ventricular ejection fraction \< 50% or left ventricular short-axis shortening fraction \< 27%.
• •4. Previous treatment with anti-programmed death (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-PD-L2 drugs, or drugs targeting another co-inhibitory T cell receptor.
• •5. Received any systemic anti-cancer treatment, including investigational drugs for the current diagnosis, before enrollment.
• •6. Received live or attenuated vaccines within 30 days before the first research intervention. Inactivated vaccines are allowed.
• •7. Received investigational drugs or used investigational devices within 4 weeks before the research intervention.
• •8. Diagnosed with lymphocyte-predominant Hodgkin lymphoma.
• •9. Diagnosed with immune deficiency or receiving chronic systemic corticosteroid therapy or any other form of immunosuppressive treatment within 7 days before the first administration of sintilimab.
• •10. Known progression of other malignancies or requiring active treatment within the past 3 years.
• •11. Presence of detectable central nervous system metastasis and/or carcinomatous meningitis on radiology at the time of diagnosis.
• •12. Severe hypersensitivity (≥ grade 3) to any research treatment, including excipients.
• •13. Active autoimmune disease requiring systemic treatment within the past 2 years.
• •14. History of (non-infectious) pneumonia/interstitial pneumonitis requiring corticosteroid treatment or currently suffering from pneumonia/interstitial lung disease with active infection requiring systemic treatment.
• •15. Known history of human immunodeficiency virus (HIV) infection.
• •16. Known history of hepatitis B or active hepatitis C virus infection.
• •17. Presence of any disease, treatment, or laboratory abnormality results that may confound study results, interfere with the subject's participation throughout the study, or, in the opinion of the treating investigator, is not in the subject's best interest to participate in the study.
• •18. Known mental illness or substance abuse disorder that would interfere with cooperation with the study requirements.
• •19. Patient has not fully recovered from major surgery or has persistent postoperative complications.
• •20. Other conditions that the investigator considers should be excluded.