Linperlisib Combined With Chidamide in Patients With PTCL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Linperlisib and chidamide, Linperlisib and chidamide, Linperlisib and chidamide, cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone.
- Who it may be relevant to
- Registry conditions: Peripheral T-cell Lymphoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study
Overview
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.
Detailed description
In the phase Ib trial, participants with newly diagnosed or relapsed/refractory PTCL will receive fixed dose of chidamide (20 mg, twice a week) and escalating dose of linperlisib (40 mg, 60 mg, or 80 mg, once a day), to find out the RP2D.
The phase IIa study is an exploratory efficacy study enrolling newly diagnosed PTCL patients who receive linperlisib in combination with chidamide to evaluate the efficacy and safety of the regimen.
In the phase IIb study, participants with newly diagnosed PTCL will be randomized into experimental arm (arm A) to receive linperlisib in combination with chidamide, or control arm (arm B) to receive standard CHOP (or CHOP-like) regimen chemotherapy.
Interim efficacy assessment will be performed after three cycles of treatment. Responded participants will receive another three cycles of treatment. After a total of 6 cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait.
Interventions
- Drug Linperlisib and chidamide
Linperlisib is a selective PI3Kδ inhibitor that has been approved in mainland China for the treatment of relapsed or refractory follicular lymphoma, with a recommended monotherapy dose of 80 mg orally once daily. In this study, Linperlisib was administered at three dose levels of 40 mg, 60 mg, and 80 mg in order to determine the recommended Phase II dose (RP2D) when combined with a fixed dose of Chidamide (20 mg twice weekly). Chidamide has been approved in mainland China for the treatment of r - Drug Linperlisib and chidamide
All patients received Linperlisib at the RP2D dose once daily and Chidamide 20 mg twice weekly, with each treatment cycle lasting 3 weeks. After three cycles, an interim efficacy assessment was performed. Patients who showed a therapeutic response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles. - Drug Linperlisib and chidamide
Patients received Linperlisib at the RP2D dose once daily and Chidamide 20 mg twice weekly, with each treatment cycle lasting 3 weeks. After three cycles, an interim efficacy assessment was performed. Patients who showed a therapeutic response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles. - Drug cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
Patients receive conventional CHOP (or CHOP-like regimens such as CHOPE or EPOCH) chemotherapy, with 3 weeks for one cycle. After three cycles, an interim efficacy assessment was performed. Patients who showed a response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles.
Primary outcome measures
- Recommended Phase 2 Dose (RP2D) [Time frame: Approximately 3 months]
- CRR (Complete response rate) [Time frame: Through study completion, an average of 3 years]
Secondary outcome measures (5)
- PFS (progression-free survival) [Time frame: Through study completion, an average of about 3 years]
- OS [Time frame: Through study completion, an average of about 3 years]
- AE (Adverse event) [Time frame: Through study completion, an average of 3 years]
- Physical Functioning and Fatique as Measured by the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTCQLQ-C30) [Time frame: Cycle 1 Day 1 through follow-up period]
- Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy -Lymphoma (FACT-Lym) Subscale [Time frame: Cycle 1 Day 1 through follow-up period]
Eligibility criteria
Inclusion criteria
- Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)
- Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma, NK/T-cell lymphoma, and primary cutaneous T-cell lymphoma are not included.
- ECOG PS 0-2 at protocol entry
- Estimated life expectancy of 6 months or longer
- Measurable disease
- Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
- Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential
- Written informed consent
Exclusion criteria
- Patients previously treated with PI3K inhibitor
- Patients previously treated with chidamide (phase Ib study is not limited by this item)
- Suspected or documented central nervous system involvement by lymphoma
- Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection
- Patients with active, uncontrolled infections
- Unwillingness or inability to comply with the protocol
- Deemed 'unfit' by the treating physician
- Pregnant and/or breastfeeding women
- Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
- Patients with contraindications to chemotherapy
- Known hypersensitivity to one or more of the study drugs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 6 centers
- Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou
- Liling Zhang — Wuhan
- Yajun Li — Changsha
- Ming Jiang — Chengdu
- Huilai Zhang — Tianjin
- Cong Li — Hangzhou
Identifiers
NCT: NCT06421948 · HNSZLYYML08