A Study to Evaluate the Efficacy and Safety of the Sintilimab Plus ICE Regimen Versus ICE Regimen in the Classic Hodgkin's Lymphoma Patients (cHL) Who Have Failed the First-line Standard Chemotherapy

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04044222

Collaborator

(none)

240

Enrollment

Location

Arms

62.4

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase III trial studies the side effects of sintilimab and 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.

Condition or Disease	Intervention/Treatment	Phase
Classic Hodgkin's Lymphoma	Biological: Sintilimab Drug: Carboplatin Drug: Etoposide Drug: Ifosfamide Drug: Placebo Drug: Carboplatin Drug: Etoposide Drug: Ifosfamide	Phase 3

Detailed Description

randomized, double-blind, two arms , multicenter

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of the Sintilimab Plus ICE Regimen Versus Placebo Plus ICE Regimen in the Classic Hodgkin's Lymphoma Patients With First-line Standard Chemotherapy Failure

Actual Study Start Date :

Oct 21, 2019

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (Sintilimab, etoposide, ifosfamide, carboplatin) 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.	Biological: Sintilimab Given IV Drug: Carboplatin Given IV Drug: Etoposide Given IV Drug: Ifosfamide Given IV
Experimental: Treatment (placebo, etoposide, ifosfamide, carboplatin) 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.	Drug: Placebo Given IV Drug: Carboplatin Given IV Drug: Etoposide Given IV Drug: Ifosfamide Given IV

Arm

Intervention/Treatment

Experimental: Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)

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.

Biological: Sintilimab

Given IV

Drug: Carboplatin

Given IV

Drug: Etoposide

Given IV

Drug: Ifosfamide

Given IV

Experimental: Treatment (placebo, etoposide, ifosfamide, carboplatin)

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.

Drug: Placebo

Given IV

Drug: Carboplatin

Given IV

Drug: Etoposide

Given IV

Drug: Ifosfamide

Given IV

Outcome Measures

Primary Outcome Measures

PFS [44months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who sign the informed consent form.
Patients must have histopathologically confirmed cHL.
Patients must have not respond to the first-line standard combination chemotherapy.
Patients must have one measurable lesion (Lugano2014).
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 gents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies.
Patients must not have participate in another interventional clinical study at the same time.
Patients must not be currently receiving any other investigational agents within 4 weeks of study registration.
Patients must not have received any other form of immunosuppressive therapy within 4 weeks prior to the first dose of the study.
Patients must not have received live attenuated vaccines within 4 weeks prior to the first dose (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 not eligible.
Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation.
Patients must not be pregnant or breastfeeding.