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

Sponsor
Chinese PLA General Hospital
Study ID
NCT04514081
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Chidamide; Decitabine; Camrelizumab — DRUG
    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.
  • Decitabine+Camrelizumab — DRUG
    Decitabine+Camrelizumab

Study Details

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.

Key Dates

Start date
Aug 1, 2020
Status verified
Aug 2020
Primary completion
Aug 1, 2022
Completion
Aug 1, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chidamide+Decitabine+Camrelizumab
  • Active Comparator: Decitabine+Camrelizumab

Primary Outcome Measure

ORR assess by investigators per the 2014 Lugano classification [ Time Frame: 3 years ]

Central Contacts

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