This study enrolls newly diagnosed unfavorable stage II /stage III-IV classical Hodgkin lymphoma patients. All participants receive 2 cycles ABVD induction chemotherapy, then stratified by interim PET-CT Deauville score for differentiated treatment: standard ABVD for DS1-3, AVD plus Sintilimab for DS4, salvage chemotherapy plus autologous stem cell transplant for DS5. The primary goal is to assess 2-year progression-free survival and compare long-term survival and toxicities across subgroups, to verify whether Sintilimab addition can avoid high-dose chemo-radiotherapy for DS4 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Combination chemotherapy containing Doxorubicin, Bleomycin, Vinblastine and Dacarbazine, 2 cycles as uniform frontline induction treatment for all eligible patients.
Anti-PD-1 monoclonal antibody Sintilimab, combined with AVD chemotherapy and given as maintenance therapy for patients with iPET2 Deauville Score 4 to avoid high-dose chemo-radiotherapy.
Peking University People's Hospital
Beijing, China
2-year Progression-Free Survival (PFS)
Time from study enrollment to first disease progression or death from any cause, stratified by iPET2 Deauville score subgroups. Disease progression is confirmed by radiological imaging evaluation.
Time frame: 2 years after completion of all assigned treatment
5-year Progression-Free Survival (PFS)
Long-term progression-free survival up to 5 years after treatment completion, compared across iPET2 stratified subgroups.
Time frame: 5 years after completion of all assigned treatment
Incidence of All-Grade and Grade 3-5 Adverse Events
Rate of hematological, non-hematological and Sintilimab-related immune adverse events graded per CTCAE v5.0 during treatment and follow-up.
Time frame: Throughout treatment period and 5-year long-term follow-up
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