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NCT Number: NCT07720011

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

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.

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Key information

Conditions

Classical Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABVD chemotherapy

Drug

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

Sintilimab and AVD

Drug

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.

Primary outcomes

  1. 2-year Progression-Free Survival (PFS)

    Time frame: 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 outcomes

  1. 5-year Progression-Free Survival (PFS)

    Time frame: 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.

  2. Incidence of All-Grade and Grade 3-5 Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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