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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 for relapsed and refractory PTCLs. 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 PTCLs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linperlisib plus Chidamide | Experimental | Linperlisib combined with chidamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linperlisib in combined with Chidamide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended phase 2 dose (RP2D) | 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) | Objective response rate (ORR) for phase 2 study | 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. | recruitment to data cut-off (up to 5 years) |
| Overall survival |
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Inclusion Criteria:
Ages 18-75;
Pathologically confirmed diagnosis of PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), angioimmunoblastic T-cell lymphoma (AITL), or other PTCL subtypes that the researchers considered to be eligible;
Fulfills the criteria for relapsed/refractory lymphoma;
There must be at least one measurable lesion: for measurable lymph node, the longest diameter should be > 1.5cm, for measurable extranodal lesion, the longest diameter should be > 1.0cm;
ECOG score of 0-2;
Adequate bone marrow hematopoietic function: neutrophil count (ANC)
≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;
Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT<3UNL, TBil<2ULN, SPO2 > 93%@RA, SCr>60ml/(min·1.73m2);
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daobin Zhou, Dr | Contact | +8613901113623 | Zhoudb@pumch.cn | |
| Chong Wei, Dr | Contact | +86 13521760705 | QH5035@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing/China | 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 |
|---|---|
| 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. |
| recruitment 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 5.0 | evaluated every treatment cycle (up to 24 months) |
| Beijing Hospital | Recruiting | Beijing | China |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |