Prospective, Single-Arm, Multicenter, Phase II Study of Sintilimab in Combination With AVD for Pediatric and Adolescent Low/Moderate Risk Classical Hodgkin Lymphoma
Design: This is a prospective, single-arm, multicenter, phase II clinical trial. Study Population: Pediatric and adolescent patients aged 1 to 18 years, diagnosed with classical Hodgkin lymphoma, and classified as low-to-intermediate risk according to the Ann Arbor staging system. Treatment Plan: Sintilimab in combination with AVD chemotherapy, administered every two weeks for a planned 4-6 cycles.
• Age between 1 and 18 years, regardless of gender.
• Low-risk group: Must be a newly diagnosed patient with pathologically confirmed classical Hodgkin lymphoma, Ann Arbor stage IA or IIA, without bulky disease (defined as a mediastinal mass diameter \> 1/3 of the chest diameter on an upright chest X-ray or any lymph node with a maximum transverse diameter \> 6cm outside the mediastinum). Intermediate-risk group: Must be a newly diagnosed patient with pathologically confirmed classical Hodgkin lymphoma, Ann Arbor stage IB, IAE, IIAE, IIIA with or without bulky disease, or IA or IIA with bulky disease, or IIB without bulky disease (B symptoms defined as: weight loss \> 10%; recurrent unexplained fever with temperature \> 38°C; night sweats).
• Presence of measurable lesions.
• For male participants with reproductive potential, they must agree to the following during the intervention period to be eligible: not donating sperm, practicing abstinence according to their preferred and usual lifestyle, and agreeing to maintain abstinence or use contraception as required by the protocol unless proven to be azoospermic.
• Female participants who are not pregnant or breastfeeding, non-reproductive potential women, or those who agree to use approved contraception for at least 120 days after the last research intervention, and agree not to donate eggs (ova, oocytes) to others or freeze/store for their own reproduction during this period.
• General condition: Lansky score ≥ 50 (age \< 16 years), Karnofsky score ≥ 50 (age ≥ 16 years).
• Laboratory tests during the screening period should meet the following conditions:Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L (ANC ≥ 1.0×10\^9/L if bone marrow involvement),Platelet count (PLT) ≥ 75×10\^9/L (PLT ≥ 50×10\^9/L if bone marrow involvement),Bilirubin ≤ 1.5 times the upper limit of normal (ULN) Creatinine ≤ 1.5 times ULN (calculated according to the standard Cockcroft-Gault formula).ALT/AST ≤ 3 times ULN (can be relaxed to 5 times ULN if liver metastasis is present)
• Able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during participation in the study.
• Parents/legal guardians of pediatric or adolescent subjects have the ability to understand, consent, and sign the informed consent form (ICF) and applicable child assent form before any protocol-related procedures are initiated; subjects are able to express consent in the presence of parents/legal guardians (if applicable).