Clinical trial NCT06083701: Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
Official title: Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Peripheral T Cell Lymphoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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;

Primary outcomes:
measure: Recommended phase 2 dose (RP2D)
timeFrame: 4 weeks since the date of first dose
measure: Objective response rate (ORR)
timeFrame: evaluated every 3 months (up to 24 months)
Secondary outcomes:
measure: Progression-free survival
timeFrame: recruitment to data cut-off (up to 5 years)
measure: Overall survival
timeFrame: recruitment to data cut-off (up to 5 years)
measure: complete remission (CR) rate
timeFrame: evaluated every 3 months (up to 24 months)
measure: adverse events
timeFrame: evaluated every treatment cycle (up to 24 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing/China
city: Beijing
country: China
facility: Beijing Hospital
Study officials:
References: