Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABVD chemotherapy | Drug | — | UNRESOLVED |
| Sintilimab and AVD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- iPET2 Stratified ABVD-Based Treatment Arm
- description
- 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
- interventionNames
- Drug: ABVD chemotherapy
- Drug: Sintilimab and AVD
Primary outcomes (1)
- measure
- 2-year Progression-Free Survival (PFS)
- timeFrame
- 2 years after completion of all assigned treatment
- description
- 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 (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available