Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
- Conditions
- Peripheral T Cell Lymphoma
- Interventions
- Registration Number
- NCT06083701
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
-
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;
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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;
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ECOG score of 0-2;
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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);
- Extranodal natural killer/T cell lymphoma;
- Previously treated with PI3K inhibitors;
- Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged QT interval (> 450ms in men and > 470ms in women) within 6 months;
- Uncontrolled active infections;
- Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded);
- Pregnant or lactating women;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Linperlisib plus Chidamide Linperlisib in combined with Chidamide Linperlisib combined with chidamide
- Primary Outcome Measures
Name Time Method Recommended phase 2 dose (RP2D) 4 weeks since the date of first dose 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.
Objective response rate (ORR) evaluated every 3 months (up to 24 months) Objective response rate (ORR) for phase 2 study
- Secondary Outcome Measures
Name Time Method Progression-free survival recruitment to data cut-off (up to 5 years) 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.
Overall survival recruitment to data cut-off (up to 5 years) Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
complete remission (CR) rate evaluated every 3 months (up to 24 months) Treatment responses were assessed according to the 2014 Lugano classification criteria
adverse events evaluated every treatment cycle (up to 24 months) Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Trial Locations
- Locations (2)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing/China, China
Beijing Hospital
🇨🇳Beijing, China