Classical Hodgkin Lymphoma
Conditions
Keywords
Classical Hodgkin lymphoma, iPET2, PD-1 inhibitor, ABVD
Brief summary
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.
Interventions
Combination chemotherapy containing Doxorubicin, Bleomycin, Vinblastine and Dacarbazine, 2 cycles as uniform frontline induction treatment for all eligible patients.
DRUGSintilimab and AVD
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old; * Histologically confirmed newly diagnosed classical Hodgkin lymphoma (cHL); * Eligible to receive standard frontline ABVD induction chemotherapy for 2 cycles; * Able to complete interim PET-CT (iPET2) scan after 2 cycles ABVD for Deauville score stratification; * Adequate bone marrow, hepatic and renal function to tolerate chemotherapy and immunotherapy; * Life expectancy ≥ 6 months at enrollment; * Willing to comply with scheduled treatment, imaging follow-up and laboratory tests;
Exclusion criteria
* Prior systemic anti-lymphoma therapy, including chemotherapy, radiation, anti-PD-1/PD-L1 immunotherapy or stem cell transplantation; * Severe irreversible organ dysfunction (cardiac, pulmonary, hepatic, renal) that cannot tolerate cytotoxic chemotherapy; * Known hypersensitivity to doxorubicin, bleomycin, vinblastine, dacarbazine or sintilimab; * Active severe infection (e.g., uncontrolled sepsis, active tuberculosis, HIV infection); * Pregnant or breastfeeding female patients; * Inability to complete serial PET-CT imaging due to contraindications such as severe contrast allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Progression-Free Survival (PFS) | 2 years after completion of all assigned treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year Progression-Free Survival (PFS) | 5 years after completion of all assigned treatment | Long-term progression-free survival up to 5 years after treatment completion, compared across iPET2 stratified subgroups. |
| Incidence of All-Grade and Grade 3-5 Adverse Events | Throughout treatment period and 5-year long-term follow-up | Rate of hematological, non-hematological and Sintilimab-related immune adverse events graded per CTCAE v5.0 during treatment and follow-up. |
Countries
China
Outcome results
None listed