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

Study Overview
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Brief Summary
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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
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randomized, double-blind, two arms , multicenter

Official Title
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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

Conditions
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Classic Hodgkin's Lymphoma

Intervention / Treatment
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* Biological: Sintilimab
* Drug: Carboplatin
* Drug: Etoposide
* Drug: Ifosfamide
* Drug: Placebo
* Drug: Carboplatin
* Drug: Etoposide
* Drug: Ifosfamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)<br>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<br>* IV<br>Drug: Carboplatin<br>* IV<br>Drug: Etoposide<br>* IV<br>Drug: Ifosfamide<br>* IV<br>|
| Experimental: Treatment (placebo, etoposide, ifosfamide, carboplatin)<br>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<br>* IV<br>Drug: Carboplatin<br>* IV<br>Drug: Etoposide<br>* IV<br>Drug: Ifosfamide<br>* IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | 44months |