Actively Recruiting
PI3K delta Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP Chemotherapy in Patients With Peripheral T-cell Lymphoma: Multicenter, Open-Label Phase Ib/II Study
Led by Yanyan Liu · Updated on 2025-12-05
134
Participants Needed
6
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of linperlisib and chidamide for treating peripheral T-cell lymphoma (PTCL) in a multi-phase study. The phase Ib part aims to find the best dose of linperlisib with chidamide. Phase IIa explores how well this combination works and its safety in newly diagnosed patients. Phase IIb compares this combination to the standard CHOP chemotherapy regimen in newly diagnosed PTCL patients. In phase Ib, patients with either new or relapsed PTCL receive fixed chidamide doses twice weekly and escalating linperlisib doses once daily to determine the recommended dose for further study. In phase IIa, newly diagnosed patients receive the recommended dose of linperlisib plus chidamide every three weeks, up to six cycles. Phase IIb randomly assigns newly diagnosed patients to receive either the linperlisib and chidamide combination or the standard CHOP (or similar) chemotherapy regimen, also for six cycles. Participants undergo an interim assessment after three treatment cycles to check response. Those responding continue for three more cycles. After six cycles, patients may choose stem cell transplantation, maintenance treatment, or observation. Researchers measure response rates, progression-free survival, overall survival, adverse events, and quality of life using questionnaires. The study includes safety follow-up and lasts about three years on average per participant.
CONDITIONS
Brief 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 time of inclusion (18 to 80 years for phase Ib and IIa)
- Newly diagnosed and histologically confirmed peripheral T-cell lymphoma (PTCL); phase Ib may include relapsed/refractory PTCL
- ECOG performance status 0 to 2
- Estimated life expectancy of at least 6 months
- Measurable disease present
- Hemoglobin 8 g/dL; platelets 75 x 10E9/L (50 x 10E9/L if bone marrow involvement)
- Serum bilirubin 1.5 x upper limit of normal
- AST and/or ALT 2.5 x upper limit of normal (or 5 x if liver involvement)
- Serum creatinine 1.5 x upper limit of normal
- Left ventricular ejection fraction 50%
- Women of childbearing potential must use contraception during study and 12 months after last drug dose; men must use contraception during study and 6 months after last drug dose
- Written informed consent provided
You will not qualify if you...
- Prior treatment with PI3K inhibitors
- Prior treatment with chidamide (except in phase Ib)
- Suspected or confirmed central nervous system lymphoma involvement
- Positive HIV or active hepatitis B or C infection
- Active uncontrolled infections
- Unable or unwilling to follow study protocol
- Considered unfit by treating physician
- Pregnant or breastfeeding women
- Severe uncontrolled medical conditions not related to lymphoma
- Contraindications to chemotherapy
- Known allergy to any study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 3 weeks each)
Participants receive linperlisib combined with chidamide or standard CHOP chemotherapy in cycles of 3 weeks each. After three cycles, an interim efficacy assessment is performed. Participants who respond continue for an additional three cycles, totaling six cycles of treatment.
6 treatment cycles with assessments after 3 and 6 cycles
Duration - Up to approximately 3 years
After six cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait, with ongoing monitoring of health and disease status.
Periodic visits during follow-up as determined by treating physician
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
Z
Zheng Yan
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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