A Phase II/III Study of Linperlisib Plus CHOP Versus CHOP in Patients With Newly Diagnosed Periph… (NCT06548347) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Phase II/III Study of Linperlisib Plus CHOP Versus CHOP in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
606 participantsStarted 2024-09-10
Plain-language summary
This is a Phase II/III, international multiple center study to evaluate the efficacy, safety, and PK of Linperlisib plus CHOP and CHOP in adult patients with Newly Diagnosed Peripheral T Cell Lymphoma.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Follicular T-cell Lymphoma (FTCL). 3. Newly diagnosed and has no received systemic therapy for PTCL. 4. Has a life expectancy ≥6 months. 5. For patients with CD30+ PTCL, progressed on or are ineligible or intolerant to brentuximab vedotin, or progressed on or are ineligible or intolerant to regional standard of care if brentuximab vedotin not approved or not available.
Exclusion criteria
. Has received anti-lymphoma therapy.
. Patients with extranodal NK/T-cell lymphoma or CTCL.
. Has dropsy of serous cavity not under controlled by surgical drains or other therapy.
. Patients with peripheral T-cell lymphoma having known central nervous system (CNS) invasion (either CNS lymphoma or leptomeningeal lymphoma).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate
Timeframe: Study treatment will continue until unacceptable toxicity or documented disease progression, or for 2 years, whichever is earlier.
2
progression-free survival
Timeframe: Study treatment will continue until unacceptable toxicity or documented disease progression, or for 2 years, whichever is earlier.
. Has received systemic steroids (in dosing exceeding 20 mg daily of prednisone equivalent) within 14 days of the first dose of study treatment.
. Presence of multiple factors affecting drug administration and absorption such as inability to swallow, diarrhea of CTCAE Grade \>1, and ileus. Use of any drug that may result in QT prolongation (e.g., antiarrhythmic agents) cannot be interrupted during the study.
. Has a history of or concurrent interstitial lung disease of any severity and/or severely impaired lung function.
. Has active viral, bacterial, fungal infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment. Routine antimicrobial prophylaxis is permitted.