Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor

Sponsor
Chinese PLA General Hospital
Study ID
NCT04337606
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Chidamide — 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.
  • Decitabine — DRUG
    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 — DRUG
    Camrelizumab is a humanized anti-PD-1 monoclonal antibody.

Study Details

This is a Phase I/II clinical trial for patients with r/r Non-Hodgkin's Lymphoma relapsed after chimeric antigen receptor T cells infusion. The purpose is to evaluate the safety and efficacy of the treatment with chidamide in combination with decitabine.

Key Dates

Start date
Apr 4, 2020
Status verified
Apr 2020
Primary completion
Apr 4, 2024
Completion
Apr 4, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: chidamide in combination with decitabine
    chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks
  • Experimental: decitabine in combination with Camrelizumab
    decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6

Primary Outcome Measure

CR rate [ Time Frame: 2 years ]

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