Linperlisib

Clinical trials are studying Linperlisib in people with relapsed or refractory peripheral T/NK cell lymphoma and cutaneous T cell lymphoma. These studies look at how well the treatment works and how safe it is in these hard-to-treat cancers. The main goal is to measure response rates in patients whose disease has come back or no longer responds to prior treatment.

Table of contents

Trial overview

The available clinical trial studied Linperlisib in people with relapsed or refractory peripheral T/NK cell lymphoma and cutaneous T cell lymphoma.[1] The study title also lists Linperlisib as YY-20394.[1] This trial was designed to see how well the treatment worked in these hard-to-treat cancers.[1]

Who was studied

The trial focused on adults with lymphoma that had come back after treatment or had not responded to earlier treatment.[1] In simple terms, “relapsed” means the disease returned, and “refractory” means it did not improve with treatment.[1] Two disease groups were included: peripheral T/NK cell lymphoma, also called PTCL, and cutaneous T cell lymphoma, also called CTCL.[1]

Study design and phase

This was an interventional study, which means the research team gave a planned treatment rather than only observing patients.[1] It was a Phase 2 trial, a stage that usually looks at whether a treatment shows signs of benefit and continues to collect safety information.[1] The study was completed and enrolled 107 participants.[1]

What was measured

The main endpoint was overall response rate, often shortened to ORR.[1] ORR combines complete response and partial response, meaning the cancer either disappeared on testing or became smaller.[1] For PTCL, the response was measured from the start of treatment to the first documented response using Lugano 2014 Response Criteria for non-Hodgkin lymphoma.[1] For CTCL, response was based on the Olsen Global Response Score.[1] The brief summary says an Independent Radiology Review Committee reviewed the results, which means outside experts checked scan findings separately.[1]

Trial status and size

The trial status is listed as Completed.[1] It included 107 participants, which gives a moderate-sized group for a Phase 2 cancer study.[1] The available data do not provide extra details on secondary endpoints beyond the main response measure.[1]

What this means for patients

Based on the trial record, Linperlisib has been studied in a specific group of patients with difficult lymphoma types that had already resisted or returned after treatment.[1] The research goal was not broad use in many diseases, but a focused test in PTCL and CTCL.[1] Because the study was Phase 2, it was mainly about learning whether the treatment shows enough activity to justify further research.[1]

Aspect Details
Drug Name Linperlisib (also known as YY-20394)
Drug Class PI3K-δ inhibitor
Administration Oral, typically once daily
Dosage Range 40mg to 80mg daily (varies by trial)
Target Conditions Various lymphomas (B-cell, T-cell, NK/T-cell), Large granular T lymphocytic leukemia, Autoimmune hemolytic anemia
Trial Phases Phase I, II, III, and IV
Combination Therapies CHOP, Camrelizumab, Pegaspargase, EZH2 inhibitors
Primary Outcomes Overall response rate, Progression-free survival, Safety profile
Secondary Outcomes Complete response rate, Overall survival, Duration of response, Quality of life measures

Ongoing Clinical Trials on Linperlisib

  • Study of Linperlisib for Patients with Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell Lymphoma

    Not recruiting

    2 1 1
    Investigated drugs:
    Italy

Glossary

  • Clinical trial: A research study in people that tests a medical treatment or strategy to learn if it is safe and how well it works.
  • Phase 2: A study stage that usually looks more closely at whether a treatment works and gathers more safety information.
  • Interventional study: A study where participants receive a treatment or other planned intervention as part of the research.
  • Relapsed: A disease that comes back after it had improved or seemed to go away.
  • Refractory: A disease that does not respond well to treatment.
  • Peripheral T/NK cell lymphoma: A type of lymphoma that starts in certain immune cells called T cells or natural killer cells.
  • Cutaneous T cell lymphoma: A type of lymphoma that mainly affects the skin and starts in T cells.
  • Overall response rate: The number of patients whose cancer shrinks or disappears after treatment.
  • Complete response: No clear sign of cancer is found after treatment.
  • Partial response: The cancer gets smaller, but does not disappear completely.
  • Independent Radiology Review Committee: A group of experts who review scan results separately to judge how well treatment is working.

References

  1. https://clinicaltrials.gov/study/2022-501431-16-00