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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (sintilimab,chidamide and azacitidine) | Experimental | Sintilimab: 200 mg IV, Q3W, d1 Chidamid: 30 mg PO, BIW, d1, d4 Azacidine: 100 mg SC, Q3W, d1-7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 200 mg IV, every 3 weeks, d1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate (CRR) by Lugano 2014 up to 24 months | Proportion of subjects who achieve complete response (CR) by Lugano 2014 response criteria | Up to 24 months |
| Duration of response (DOR) up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of potential biomarkers predictive of response to treatment | The correlation of clinical response with the expression of PD-L1, CD4, CD8, CD68 in tumor environment | Up to 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqin Song, Doctor | Contact | 010-88196115 | songyuqin622@163.com | |
| Zhitao Ying, Doctor | Contact | 010-88196115 | yingzhitao001@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuqin Song, Doctor | Cancer Hospital of Beijing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Chidamide | Drug | 30 mg PO, 2 times every week, d1 and d4 |
|
|
| Azacidine | Drug | 100 mg SC, every 3 weeks, d1 to d7 |
|
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DOR is defined as the time from the date of first remission to the date of disease progression or death whichever is earlier
| 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 | Up to 24 months |
| Overall survival (OS) up to 24 months | OS is defined as the time from treatment to the date of death | 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 | Up to 90 days post-treatment |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |