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

September 12, 2022 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

randomized, double-blind, two arms , multicenter

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.
Drug: Carboplatin
IV
Drug: Etoposide
IV
Biological: Sintilimab
IV
Drug: Ifosfamide
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
IV
Drug: Carboplatin
IV
Drug: Etoposide
IV
Drug: Ifosfamide
IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: 44months
44months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 21, 2019

Primary Completion (ANTICIPATED)

July 30, 2023

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (ACTUAL)

August 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI308B301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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