Actively Recruiting
Linperlisib Combined With Chidamide in Patients With PTCL
Led by Yanyan Liu · Updated on 2025-12-05
134
Participants Needed
6
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL). The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients. The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.
CONDITIONS
Official Title
Linperlisib Combined With Chidamide in Patients With PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at inclusion (18 to 80 years for phase Ib and IIa)
- Newly diagnosed and confirmed Peripheral T-cell Lymphoma (PTCL); phase Ib also includes relapsed/refractory PTCL
- ECOG performance status of 0 to 2 at study start
- Expected to live at least 6 months
- Measurable disease present
- Hemoglobin ≥ 8 g/dL; Platelets ≥ 75 x 10^9/L; Neutrophils ≥ 1.0 x 10^9/L; Platelets ≥ 50 x 10^9/L allowed if bone marrow involved
- Serum bilirubin ≤ 1.5 times upper normal limit; AST/ALT ≤ 2.5 times upper normal limit or ≤ 5 times if liver involved
- Serum creatinine ≤ 1.5 times upper normal limit
- Left ventricular ejection fraction ≥ 50%
- Women of childbearing potential must use effective contraception during study and 12 months after
- Male patients must use contraception during study and 6 months after if partner is of childbearing potential
- Provided written informed consent
You will not qualify if you...
- Prior treatment with a PI3K inhibitor (except phase Ib)
- Prior treatment with chidamide (except phase Ib)
- Suspected or confirmed lymphoma involvement in central nervous system
- Positive for HIV or active hepatitis B or C infection
- Active, uncontrolled infections
- Unable or unwilling to follow study procedures
- Deemed unfit by treating physician
- Pregnant or breastfeeding women
- Severe uncontrolled medical conditions unrelated to lymphoma
- Contraindications to chemotherapy
- Known allergy to study drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450008
Actively Recruiting
2
Liling Zhang
Wuhan, Hubei, China, 430022
Actively Recruiting
3
Yajun Li
Changsha, Hunan, China, 410003
Actively Recruiting
4
Ming Jiang
Chengdu, Sichuan, China, 610041
Actively Recruiting
5
Huilai Zhang
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
6
Cong Li
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yanyan Liu
CONTACT
Z
Zheng Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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