Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma (NCT05949944) | Clinical Trial Compass
RecruitingPhase 1/2
Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma
China50 participantsStarted 2023-08-15
Plain-language summary
This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.
Who can participate
Age range
18 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.
Inclusion criteria
. Histologically confirmed PTCL, including peripheral T-cell lymphoma non-specific type (PTCL NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma and liver spleen T-cell lymphoma;
. Has not received anti-tumor treatment in the past;
Exclusion criteria
. Age ≥18 years old, regardless of gender;
. Whole body physical condition score (ECOG) 0-2;
. Expected survival time\>3 months;
. Adequate bone marrow and organ functions;
. Not accompanied by hemophagocytic syndrome; If the patient is accompanied by clinically diagnosed hemophagocytic syndrome, after targeted anti hemophagocytic syndrome drug treatment, the researcher evaluates the patient's general physical condition to determine whether they can be enrolled.
. Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.
. Received PI3K inhibitor treatment before enrollment;
. A history of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years;
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
Dose-limiting toxicity (DLT, Phase Ib)
Timeframe: The first cycle of linperlisib in combination with R-CHOP regimen (21 days)
2
Complete remission rate (CR rate) based on the 2014 Lugano evaluation criteria (Phase II)