This is a single-arm, single-center Phase II clinical trial for patients with relapsed or refractory Peripheral T-cell lymphoma (PTCL). Immunotherapy with anti-PD-1 antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chidamide and azacitidine may respectively stop the growth of tumor cells by blocking histone deacetylation and DNA methylation enzymes needed for cell growth. Giving chidamide and azacitidine with sintilimab these three drugs may work better than single drug or combination of two drugs in treating patients with relapsed or refractory peripheral T-cell lymphoma.
PRIMARY OBJECTIVES: To determine the objective response rate (ORR). SECONDARY OBJECTIVES: 1. To determine the complete response rate (CRR). 2. To determine the duration of response (DOR). 3. To determine the progression free survival (PFS). 4. To determine the overall survival (OS). 5. To determine the safety. EXPLORATORY OBJECTIVES: Assess the correlation between the expression of PD-L1, CD4, CD8, CD68 in tumor microenvironment and the efficacy of combined therapy in relapsed or refractory peripheral T-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
200 mg IV, every 3 weeks, d1
30 mg PO, 2 times every week, d1 and d4
100 mg SC, every 3 weeks, d1 to d7
Beijing
Beijing, Beijing Municipality, China
Objective response rate (ORR) by Lugano 2014 up to 24 months
Proportion of subjects who achieve complete response (CR) or partial response (PR) by Lugano 2014 response criteria
Time frame: Up to 24 months
Complete remission rate (CRR) by Lugano 2014 up to 24 months
Proportion of subjects who achieve complete response (CR) by Lugano 2014 response criteria
Time frame: Up to 24 months
Duration of response (DOR) up to 24 months
DOR is defined as the time from the date of first remission to the date of disease progression or death whichever is earlier
Time frame: Up to 24 months
Progression free survival (PFS) up to 24 months
PFS is defined as the time from the treatment date to the date of disease progression per the Lugano 2014 Response Criteria or death regardless of cause
Time frame: Up to 24 months
Overall survival (OS) up to 24 months
OS is defined as the time from treatment to the date of death
Time frame: Up to 24 months
Incidence and Severity of adverse events by CTCAE v5.0 up to 90 days post-treatment
Incidence and Severity of adverse events as assessed by CTCAE v5.0
Time frame: Up to 90 days post-treatment
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