Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Study Overview
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Brief Summary
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This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.

Official Title
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An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Camrelizumab and Decitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 2 12 to 75 years of age. 3 ECOG performance of less than 2. 4 Life expectancy of at least 3 months. 5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria. 6 Subjects must have received at least two lines of prior regimens without Anti-PD-1 antibody treatment history, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 7 Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month . 4 Prior organ allograft. 5 Women who are pregnant or breastfeeding. 6 Women with a positive pregnancy test on enrollment or prior to nvestigational product administration. 7 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: Camrelizumab plus decitabine<br>Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks. | Drug: Camrelizumab and 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. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of response | Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause. | 5 years | 
| Progression free survival | Time measured from the day of treatment to the date of first documented progression, or death from any cause | 5 years |