About this trial
Study Purpose: To evaluate the efficacy and safety of sintilimab in combination with AVD chemotherapy for the treatment of pediatric and adolescent patients with low-to-intermediate risk classical Hodgkin lymphoma (cHL).
Study 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
History of solid organ transplantation at any time or allogeneic hematopoietic stem cell transplantation within the past 5 years.
Female participants with reproductive potential who test positive for pregnancy on a urine pregnancy test within 24 hours before the first dose.
Baseline left ventricular ejection fraction < 50% or left ventricular short-axis shortening fraction < 27%.
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.
Trial design
Treatments tested in this trial
- Sintilimab in combination with AVD chemotherapy