Interim PET/CT-adapted Use of PD-1 Inhibitor Combined With De-escalated Chemotherapy-AVD in Classic Hodgkin Lymphoma | NCT07720011

NCT07720011

Overview

NCT ID: NCT07720011
Lead Sponsor: Peking University People's HospitalOTHER
Official Title: A Prospective Single-institution Phase II Study of Interim PET/CT-adapted PD-1 Inhibitor Addition to First-line Chemotherapy for Unfavorable Stage II and Stage III/IV Classical Hodgkin Lymphoma to Omit High-dose Chemotherapy and Radiotherapy
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.
Conditions: Classical Hodgkin Lymphoma

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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