Pirtobrutinib + R-CHOP for Untreated Non-GCB DLBCL
China34 participantsStarted 2026-07-30
Plain-language summary
To evaluate the efficacy and safety of pirtobrutinib combined with R-CHOP in patients with newly diagnosed non-GCB diffuse large B-cell lymphoma (DLBCL)
Who can participate
Age range
18 Years – 80 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
. Histopathologically confirmed non-GCB diffuse large B-cell lymphoma (DLBCL) (per the 2016 WHO diagnostic criteria);
. Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per the 2014 Lugano Criteria);
. Age 18-80 years, with estimated survival \> 3 months;
. No prior anti-lymphoma treatment;
. Able to provide written informed consent and comply with scheduled study visits and required procedures specified in the protocol;
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
. Adequate organ and bone marrow function, defined as follows: Hematology: Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L; platelet count (PLT) ≥ 50 × 10⁹/L; hemoglobin (HGB) ≥ 8.0 g/dL. No administration of granulocyte growth factors, platelet transfusions or red blood cell transfusions within 7 days before testing. Liver function: Total serum bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (CCr) ≥ 50 mL/min. Cardiac function: New York Heart Association (NYHA) functional class \< III; left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography. Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ upper limit of normal +10 s; prothrombin time (PT) ≤ upper limit of normal +3 s. Thyroid function: Baseline thyroid-stimulating hormone (TSH) within normal range, or abnormal baseline TSH with normal T3/T4 and absence of related clinical symptoms.
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
Complete Response Rate (CRR) after 6 cycles of induction therapy
Timeframe: week 18，at the end of 6 cycles of induction therapy（each cycle is 21 days）
. Female subjects of childbearing potential, or male subjects whose sexual partners are females of childbearing potential, must adopt effective contraceptive measures throughout the treatment period and for 90 days after the last treatment administration.
Exclusion criteria
. Central nervous system involvement;
. History of hypersensitivity to the study drug, similar agents, or excipients;
. Concurrent other malignancies requiring treatment or intervention;
. Major surgical procedure performed within 4 weeks prior to treatment (excluding vascular access catheterization or biopsy);
. Any life-threatening disease, medical condition, or organ dysfunction that, in the Investigator's opinion, may compromise patient safety or adherence to study procedures;
. Poorly controlled cardiac symptoms or diseases, including: i. Heart failure of NYHA Class ≥ II; ii. Unstable angina pectoris; iii. Myocardial infarction within the past 12 months; iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
. Patients with active bleeding;
. Uncontrolled active systemic bacterial, viral, fungal or parasitic infection (excluding fungal nail infection), or other clinically significant active disease process that renders the patient unsuitable for participation in this trial as judged by the Investigator.