Pirtobrutinib+Pola-R-CHP for Newly Diagnosed Non-GCB DLBCL
China48 participantsStarted 2026-07-31
Plain-language summary
This is a single-arm, open-label, multicenter clinical study evaluating the efficacy and safety of pirtobrutinib combined with Pola-R-CHP in previously untreated Non-GCB DLBCL. PET/CT assessment will be performed after 3 cycles of combination therapy. Patients achieving CR/PR will continue treatment for another 3 cycles, while those with PD/SD will be discontinued from the study. Patients achieving CR/PR after 6 cycles of treatment will undergo follow-up with PET/CT or contrast-enhanced CT every 3 months during the first year and every 6 months thereafter, until disease progression, death, withdrawal of informed consent, or study completion, whichever occurs first.
Who can participate
Age range
18 Years – 65 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 Non-GCB DLBCL (per 2016 WHO diagnostic criteria);
. Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per 2014 Lugano criteria);
. Age 18-65 years, with expected survival \>3 months;
. No prior anti-lymphoma treatment;
. Signed written informed consent and ability to comply with protocol-required visits and procedures;
. ECOG performance status 0-2;
. Adequate organ and bone marrow function, defined as follows:
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.
. Women of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 90 days after the last dose.
Exclusion criteria
. Central nervous system involvement;
. History of hypersensitivity to the study drug, drugs of the same class, or excipients;
. Concurrent malignancy requiring treatment or intervention;
. Major surgery within 4 weeks prior to treatment (excluding vascular access catheter placement or biopsy);
. Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect patient safety or compliance with study procedures;
. Uncontrolled cardiac symptoms or disease, including: i. NYHA Class II or higher heart failure; ii. Unstable angina; iii. Myocardial infarction within 1 year; iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
. Active bleeding;
. Active, uncontrolled systemic bacterial, viral, fungal, or parasitic infection (excluding onychomycosis), or other clinically significant active disease process that, in the investigator's opinion, renders the patient unsuitable for clinical trial participation;