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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04044222
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

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 Phase 3

Detailed Description:
randomized, double-blind, two arms , multicenter

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 21, 2019
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. PFS [ Time Frame: 44months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who sign the informed consent form.
  2. Patients must have histopathologically confirmed cHL.
  3. Patients must have not respond to the first-line standard combination chemotherapy.
  4. Patients must have one measurable lesion (Lugano2014).
  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 gents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies.
  3. Patients must not have participate in another interventional clinical study at the same time.
  4. Patients must not be currently receiving any other investigational agents within 4 weeks of study registration.
  5. Patients must not have received any other form of immunosuppressive therapy within 4 weeks prior to the first dose of the study.
  6. 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).
  7. Patients with known immunodeficiency are ineligible .
  8. Patients with known active TB (Bacillus tuberculosis) are not eligible.
  9. Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation.
  10. Patients must not be pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044222


Contacts
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Contact: Ronghua Zhang 15267110561 ronghua.zhang@innoventbio.com
Contact: Hui Zhou 86-021-31837200 hui.zhou@innoventbio.com

Locations
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China, Beijing
Cancer hospital Chinese academy of Medical sciences Recruiting
Beijing, Beijing, China
Contact: Yuankai Shi    010-87788293    syuankaipumc@126.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04044222    
Other Study ID Numbers: CIBI308B301
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Carboplatin
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents