CompletedPhase 2

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

China130 participantsStarted 2019-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

2-year Progression-Free Survival (PFS)

Timeframe: 2 years after completion of all assigned treatment

Trial details

NCT IDNCT07720011

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More Classical Hodgkin Lymphoma trials