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

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

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 Overview

• Status: Completed
• Conditions: Classical Hodgkin Lymphoma
• Intervention / Treatment: Drug: ABVD chemotherapy; Drug: Sintilimab and AVD

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: iPET2 Stratified ABVD-Based Treatment Arm; All patients receive 2 cycles of frontline ABVD induction chemotherapy first, then treatment is stratified by iPET2 Deauville score: DS 1-3: Complete standard full-course ABVD chemotherapy; DS 4: AVD combined with Sintilimab maintenance to avoid high-dose chemo-radiotherapy; DS 5: Salvage intensive chemotherapy followed by autologous stem cell transplantation

Drug: ABVD chemotherapy; Combination chemotherapy containing Doxorubicin, Bleomycin, Vinblastine and Dacarbazine, 2 cycles as uniform frontline induction treatment for all eligible patients.; Drug: Sintilimab 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years after completion of all assigned treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year Progression-Free Survival (PFS)	Long-term progression-free survival up to 5 years after treatment completion, compared across iPET2 stratified subgroups.	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.	Throughout treatment period and 5-year long-term follow-up

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: PD-1 inhibitor; ABVD; Classical Hodgkin lymphoma; iPET2
• Additional Relevant MeSH Terms: sintilimab
• Other Study ID Numbers: PET2-cHL-PD1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No