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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04044222

Enrollment

240

Registered

2019-08-05

Start date

2019-10-21

Completion date

2024-12-31

Last updated

2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classic Hodgkin's Lymphoma

Brief summary

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.

Detailed description

randomized, double-blind, two arms , multicenter

Interventions

BIOLOGICALSintilimab

DRUGCarboplatin

DRUGEtoposide

DRUGIfosfamide

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
PFS	44months

Countries

China

Contacts

Primary ContactRonghua Zhang

ronghua.zhang@innoventbio.com15267110561

Backup ContactHui Zhou

hui.zhou@innoventbio.com86-021-31837200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026