In short
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.
Key points
- Clinical trial data for Linperlisib are limited to one completed Phase 2 study. The trial enrolled 107 patients with relapsed or refractory peripheral T/NK cell lymphoma or cutaneous T cell lymphoma. Researchers mainly looked at overall response rate, which measures how many patients had a complete or partial response. The study also used independent review of scan results to judge treatment response. This makes the trial focused on hard-to-treat lymphoma populations.
At a glance
- 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
Trial overview
The available clinical trial studied Linperlisib in people with relapsed or refractory peripheral T/NK cell lymphoma and cutaneous T cell lymphoma. The study title also lists Linperlisib as YY-20394. This trial was designed to see how well the treatment worked in these hard-to-treat cancers.
Who was studied
The trial focused on adults with lymphoma that had come back after treatment or had not responded to earlier treatment. In simple terms, “relapsed” means the disease returned, and “refractory” means it did not improve with treatment. Two disease groups were included: peripheral T/NK cell lymphoma, also called PTCL, and cutaneous T cell lymphoma, also called CTCL.
Study design and phase
This was an interventional study, which means the research team gave a planned treatment rather than only observing patients. 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. The study was completed and enrolled 107 participants.
What was measured
The main endpoint was overall response rate, often shortened to ORR. ORR combines complete response and partial response, meaning the cancer either disappeared on testing or became smaller. 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. For CTCL, response was based on the Olsen Global Response Score. The brief summary says an Independent Radiology Review Committee reviewed the results, which means outside experts checked scan findings separately.
Trial status and size
The trial status is listed as Completed. It included 107 participants, which gives a moderate-sized group for a Phase 2 cancer study. The available data do not provide extra details on secondary endpoints beyond the main response measure.
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. The research goal was not broad use in many diseases, but a focused test in PTCL and CTCL. Because the study was Phase 2, it was mainly about learning whether the treatment shows enough activity to justify further research.