Linperlisib Combined With Chidamide in Patients With PTCL

Trial Title: Linperlisib Combined With Chidamide in Patients With PTCL

NCT ID: NCT06421948

Condition: Peripheral T-cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Prednisone
Cyclophosphamide
Doxorubicin
Vincristine
Epirubicin

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Linperlisib and chidamide
Description: A combination of linperlisib and chidamide will be administered for 6 cycles in patients responded to treatment.
Arm group label: Orally administered, targeted therapy

Intervention type: Drug
Intervention name: cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
Description: A combination of cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone (CHOP) will be administered for 6 cycles in patients responded to treatment.
Arm group label: Intravenously chemotherapy

Summary: The goal of this clinical trial is to determine the maximum tolerated dose (MTD) of PI3Kδ inhibitor linperlisib when combined with fixed dose of HDAC inhibitor chidamide in participants with peripheral T-cell lymphoma (PTCL), and to compare the combination of linperlisib and chidamide to standard CHOP (cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone) regimen chemotherapy in the frontline treatment of PTCL to see which therapy is better.

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 optimal dose of linperlisib. In the phase II trial, 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 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib 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 and NK/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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Affiliated Cancer Hospital of Zhengzhou University

Address:
City: Zhengzhou
Zip: 450008
Country: China

Status: Recruiting

Contact:
Last name: Yanyan Liu

Phone: 86-037165587791
Email: yyliu@zzu.edu.cn

Contact backup:
Last name: Zheng Yan

Phone: 86+13598097015
Email: zlyyyanzheng3920@zzu.edu.cn

Start date: January 1, 2024

Completion date: May 31, 2026

Lead sponsor:
Agency: Yanyan Liu
Agency class: Other

Source: Henan Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06421948