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HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono therapy in PTCL. The combination of duvelisib and romidepsin is highly active against relapsed and refractory T-cell lymphomas including cutaneous T-cell lymphomas (CTCLs). The aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory CTCLs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linperlisib + Chidamide | Experimental | Linperlisib combined with chidamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linperlisib in combined with Chidamide | Drug | Phase 1: dose escalation phase. Drug Linperlisib: 3 dose level of 40mg, 60mg, 80mg qd; Drug Chidamide: fixed dose of 20mg twice weekly. Phase 2:dose expansion phase. Drug Linperlisib: RP2D established in the phase I study; Drug Chidamide: fixed dose of 20mg twice weekly in a 4-week cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended phase 2 dose (RP2D)(Phase 1) | Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of linperlisib. | 4 weeks since the date of first dose |
| Objective response rate (ORR)(Phase 2) | evaluated every 3 months (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first. | Baseline up to data cut-off (up to 5 years) |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhang | Contact | +8613681473557 | vv1223@vip.sina.com | |
| Chong Wei | Contact | +8613521760705 | QH5035@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40601335 | Derived | Pang Z, Wang Y, Liu Z, Zhang S, Wei C, Xu Z, Wang Z, Chen H, Liu J, Zhang W. Linperlisib Plus Chidamide in Relapsed or Refractory Cutaneous T-Cell Lymphoma: A Nonrandomized Clinical Trial. JAMA Dermatol. 2025 Sep 1;161(9):923-930. doi: 10.1001/jamadermatol.2025.1926. |
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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|
Overall survival was defined as the time from the date of enrollment to the date of death from any cause. |
| Baseline up to data cut-off (up to 5 years) |
| complete remission (CR) rate | Treatment responses were assessed according to the 2014 Lugano classification criteria | evaluated every 3 months (up to 24 months) |
| adverse events | Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | evaluated every treatment cycle (up to 24 months) |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |