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

Classic Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044222
• Other study ID #: CIBI308B301
• Status: Recruiting
• Phase: Phase 3
• Start date: October 21, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Ronghua Zhang
• Phone: 15267110561
• Email: ronghua.zhang[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

randomized, double-blind, two arms , multicenter

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Classic Hodgkin's Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• Sintilimab
IV

Drug:
• Carboplatin
IV
• Etoposide
IV
• Ifosfamide
IV
• Placebo
IV
• Carboplatin
IV
• Etoposide
IV
• Ifosfamide
IV

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		44months