Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma

Study Overview
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Brief Summary
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This is a Phase II clinical trial for Decitabine plus Camrelizumab resistant/relapsed patients with Hodgkin Lymphoma. The purpose is to evaluate the efficacy and safety of the combination therapy of Chidamide plus Decitabine Plus Camrelizumab.

Official Title
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Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma: an Open-label, Single Arm, Phase II Trial

Conditions
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Hodgkin Lymphoma

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


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 be relapsed or resistant for the treatment of Decitabine plus Camrelizumab. 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 one 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 (eg, infectious disease) 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chidamide in combination with camrelizumab plus decitabine<br>chidamide 10mg/day, days 1-4, 20mg/day, day 8, 11, 15, 18; camrelizumab 200mg d6; decitabine 10 mg/day, days 1-5, every 3 weeks | Drug: Chidamide<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.<br>Drug: Camrelizumab<br>* Camrelizumab is a humanized anti-PD-1 monoclonal antibody.<br>Drug: Decitabine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | ORR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects | 3 years | 
| Adverse effects | Adverse effects were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). | 3 years |