NCT04044222

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Classic Hodgkin's Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Sintilimab	IV
DRUG	Carboplatin	IV
DRUG	Etoposide	IV
DRUG	Ifosfamide	IV
DRUG	Placebo	IV
DRUG	Carboplatin	IV
DRUG	Etoposide	IV
DRUG	Ifosfamide	IV

Timeline

• Start date: 2019-10-21
• Primary completion: 2023-07-30
• Completion: 2024-12-31
• First posted: 2019-08-05
• Last updated: 2022-09-14

Locations

1 site across 1 country: China