Linperlisib Combined With Chidamide in Patients With PTCL

Last updated: May 14, 2024
Sponsor: Yanyan Liu
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Non-hodgkin's Lymphoma

T-cell Lymphoma

Treatment

cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone

Linperlisib and chidamide

Clinical Study ID

NCT06421948
HNSZLYYML08
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 studyincludes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large celllymphoma 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 marrowinvolvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serumglutamic-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 bylymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%

  • Women of childbearing potential must use safe anticonception (e.g. contraceptivepills, intrauterine devices etc.) during the study and 12 months after the lastadministration of study drugs; Male patients must use contraception for the durationof the study and 6 months after the last administration of study drugs if hispartner is of childbearing potential

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Patients previously treated with PI3K inhibitor

  • Patients previously treated with chidamide (phase Ib study is not limited by thisitem)

  • 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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
Phase: 1/2
Study Start date:
January 01, 2024
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Affiliated Cancer Hospital of Zhengzhou University

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

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