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
NCT ID: NCT04044222
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2019-10-21
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
Sintilimab
IV
Carboplatin
IV
Etoposide
IV
Ifosfamide
IV
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.
Placebo
IV
Carboplatin
IV
Etoposide
IV
Ifosfamide
IV
Interventions
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Sintilimab
IV
Carboplatin
IV
Etoposide
IV
Ifosfamide
IV
Placebo
IV
Carboplatin
IV
Etoposide
IV
Ifosfamide
IV
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIBI308B301
Identifier Type: -
Identifier Source: org_study_id
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