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Trial Title:
Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
NCT ID:
NCT06083701
Condition:
Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Linperlisib in combined with Chidamide
Description:
- Phase 1: dose escalation phase. Drug Linperlisib: 3 dose level of 40mg, 60mg, 80mg
qd; Drug Chidamide: fixed dose of 20mg twice weekly in a 4-week cycle;
- 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;
Arm group label:
Linperlisib plus Chidamide
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Daobin Zhou, PhD&MD
Phone:
010-69155020
Email:
zhoudb@pumch.cn
Facility:
Name:
Beijing Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Liu
Start date:
September 25, 2023
Completion date:
September 25, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06083701
