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This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of linperlisib combined with chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linperlisib Combined with Chidamide | Experimental | Patients will receive Chidamide 20 mg orally twice weekly (biw) in combination with Linperlisib at the RP2D (80 mg or 60 mg, po, qd). Each treatment cycle is 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linperlisib | Drug | Linperlisib: 80 mg or 60 mg, po, qd (phase Ib); RP2D (phase II) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) for Phase 1b | To identify the DLT | The first cycle (each cycle is 28 days) after administration |
| Overall response rate(ORR) for Phase 2 | The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | Defined as the proportion of patients who achieve complete remission as the best response | Up to 24 months |
| Duration of Response(DOR) | To investigate the preliminary anti-tumor efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai | Contact | +862087342823 | caiqq@sysucc.org.cn |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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| Chidamide | Drug | Chidamide: 20mg, po, biw |
|
| Up to 4 years |
| Progression-free survival(PFS) | To investigate the preliminary anti-tumor efficacy | Up to 4 years |
| Overall survival(OS) | To investigate the preliminary anti-tumor efficacy | Up to 4 years |