The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.

Study Overview
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Brief Summary
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This open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.

Official Title
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A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.

Conditions
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Hodgkin Lymphoma, Anti-PD-1 Antibody Resistant

Intervention / Treatment
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* Drug: Chidamide; Decitabine; Camrelizumab
* Drug: Decitabine+Camrelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 12 to 75 years of age. ECOG performance of less than 2. Life expectancy of at least 3 months. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria. Subjects must have received Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month. Prior organ allograft. Women who are pregnant or breastfeeding. Women with a positive pregnancy test on enrollment or prior to investigational product administration. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chidamide+Decitabine+Camrelizumab<br> | Drug: Chidamide; Decitabine; Camrelizumab<br>* Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.<br>|
| Active Comparator: Decitabine+Camrelizumab<br> | Drug: Decitabine+Camrelizumab<br>* Decitabine+Camrelizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR assess by investigators per the 2014 Lugano classification | rate of subjects achieved objective response in all evaluable subjects | 3 years | 
| Number of Subjects with treatment-related adverse events (AEs) | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. | 3 years |