NCT07720011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

7.1 years

First QC Date

July 18, 2026

Last Update Submit

July 18, 2026

Conditions

Classical Hodgkin Lymphoma

Keywords

Classical Hodgkin lymphomaiPET2PD-1 inhibitorABVD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 5-year Progression-Free Survival (PFS)

    5 years after completion of all assigned treatment

  • Incidence of All-Grade and Grade 3-5 Adverse Events

    Throughout treatment period and 5-year long-term follow-up

Study Arms (1)

iPET2 Stratified ABVD-Based Treatment Arm

EXPERIMENTAL

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 chemotherapyDrug: Sintilimab and AVD

Interventions

ABVD chemotherapyDRUG

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

iPET2 Stratified ABVD-Based Treatment Arm
Sintilimab and AVDDRUG

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.

iPET2 Stratified ABVD-Based Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Interventions

sintilimab

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 18, 2026

First Posted

July 22, 2026

Study Start

February 1, 2019

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations

CN(1)