Clinical trial · Interventional
A Study to Evaluate the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus ICE Regimen in Classic Hodgkin's Lymphoma Patients (cHL) Who Have Failed First-line Standard Chemotherapy
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus a Placebo Plus ICE Regimen in Classic Hodgkin's Lymphoma Patients With First-line Standard Chemotherapy Failure
NCT04044222CI-TRIAL-00060841unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.
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 |
|---|---|---|---|
| Classic Hodgkin's Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Sintilimab | Biological | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
- description
- Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
- interventionNames
- Biological: Sintilimab
- Drug: Carboplatin
- Drug: Etoposide
- Drug: Ifosfamide
- type
- EXPERIMENTAL
- label
- Treatment (placebo, etoposide, ifosfamide, carboplatin)
- description
- Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.
- interventionNames
- Drug: Placebo
- Drug: Carboplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent 2. Histopathologically confirmed cHL 3. Failed first-line standard combination chemotherapy 4. One measurable lesion (Lugano 2014) 5. Eastern Cooperative Oncology Group (ECOG) of 0-1 6. Male or female aged ≥18 years 7. Patients must have adequate organ and bone marrow function Exclusion Criteria: 1. Patients must not have known central nervous system (CNS) involvement 2. Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 agents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies 3. Patients may not simultaneously participate in another interventional clinical study 4. Patients may not receive any other investigational agents within 4 weeks of study registration 5. Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug 6. Patients may not receive live attenuated vaccines within 4 weeks prior to the first dose of study drug (or plan to receive live attenuated vaccines during the study period) 7. Patients with known immunodeficiency are ineligible 8. Patients with known active TB (Bacillus tuberculosis) are ineligible 9. Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation 10. Patients must not be pregnant or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.