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This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx | Experimental | In Cohort 1, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Mitoxantrone Hydrochloride Liposome, with an initial dose of 15mg/mĀ² of Liposomal Mitoxantrone. Two dose groups are designed: 15mg/mĀ² and 18mg/mĀ². Each treatment cycle is 28 days. The Mitoxantrone Hydrochloride Liposome injection will be combined with Golidocitinib(150mg, qd) at the RP2D dose level for an extension study. In Cohort 2, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Chidamide, with an initial dose of 20 mg (biw) of Chidamide. Two dose groups are designed: 20 mg and 30 mg. Each treatment cycle is 28 days. The Chidamide will be combined with Golidocitinib (150mg, qd) at the RP2D dose level for an extension study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golidocitinib | Drug | 150mg, po, qd; |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Maximum tolerated dose (MTD) for Phase 1b | To identify the MTD | The first cycle after administration |
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | China |
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| Mitoxantrone Hydrochloride Liposome | Drug | Cohort 1: 15 mg/m2, IV, D1 and 18 mg/m2, IV, D1 (phase Ib); RP2D (II study) |
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| Chidamide | Drug | Cohort 2: Chidamideļ¼20mg/30mg, po, Biw (phase Ib); RP2D (phase II study) |
|
| 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 |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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