Back to results

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

Primary Purpose

Classic Hodgkin's Lymphoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Sintilimab

Carboplatin

Etoposide

Ifosfamide

Placebo

Carboplatin

Etoposide

Ifosfamide

About this trial

This is an interventional treatment trial for Classic Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent
Histopathologically confirmed cHL
Failed first-line standard combination chemotherapy
One measurable lesion (Lugano 2014)
Eastern Cooperative Oncology Group (ECOG) of 0-1
Male or female aged ≥18 years
Patients must have adequate organ and bone marrow function

Exclusion Criteria:

Patients must not have known central nervous system (CNS) involvement
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
Patients may not simultaneously participate in another interventional clinical study
Patients may not receive any other investigational agents within 4 weeks of study registration
Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
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)
Patients with known immunodeficiency are ineligible
Patients with known active TB (Bacillus tuberculosis) are ineligible
Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
Patients must not be pregnant or breastfeeding

Sites / Locations

Cancer Hospital Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)

Treatment (placebo, etoposide, ifosfamide, carboplatin)

Arm 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.

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.

Outcomes

Primary Outcome Measures

PFS

Secondary Outcome Measures

Full Information

NCT ID

NCT04044222

First Posted

August 1, 2019

Last Updated

September 12, 2022

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04044222

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 21, 2019 (Actual)

Primary Completion Date

July 30, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Classic Hodgkin's Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)

Arm Type

Experimental

Arm Description

Arm Title

Treatment (placebo, etoposide, ifosfamide, carboplatin)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Sintilimab

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Ifosfamide

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Ifosfamide

Intervention Description

Primary Outcome Measure Information:

Title

PFS

Time Frame

44months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent Histopathologically confirmed cHL Failed first-line standard combination chemotherapy One measurable lesion (Lugano 2014) Eastern Cooperative Oncology Group (ECOG) of 0-1 Male or female aged ≥18 years Patients must have adequate organ and bone marrow function Exclusion Criteria: Patients must not have known central nervous system (CNS) involvement 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 Patients may not simultaneously participate in another interventional clinical study Patients may not receive any other investigational agents within 4 weeks of study registration Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug 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) Patients with known immunodeficiency are ineligible Patients with known active TB (Bacillus tuberculosis) are ineligible Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation Patients must not be pregnant or breastfeeding

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronghua Zhang

Phone

15267110561

ronghua.zhang@innoventbio.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Zhou

Phone

86-021-31837200

hui.zhou@innoventbio.com

Facility Information:

Facility Name

Cancer Hospital Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuankai Shi

Phone

010-87788293

syuankaipumc@126.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs