Can a targeted drug combo outsmart an aggressive lymphoma?
NCT ID NCT07744724
First seen Aug 04, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This phase 2 trial is testing whether adding the targeted drug pirtobrutinib to a standard chemotherapy regimen (Pola-R-CHP) can improve outcomes for people newly diagnosed with a specific, harder-to-treat subtype of diffuse large B-cell lymphoma (Non-GCB DLBCL). The study will enroll about 48 adults aged 18-65 who have not yet received treatment. Participants will receive the combination for up to six 21-day cycles, with imaging scans to check how well the cancer responds. The main goal is to see how long people live without their cancer progressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pirtobrutinib combined with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP)
- What this could lead to
- If successful, this combination could offer a more effective first-line treatment for a hard-to-treat subtype of DLBCL, potentially improving long-term survival.
- What could go wrong
- This is an early-phase, single-arm study with a small number of participants, so results may not be definitive. The combination may cause significant side effects, and not all patients will respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed Non-GCB DLBCL (per 2016 WHO diagnostic criteria); 2. Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per 2014 Lugano criteria); 3. Age 18-65 years, with expected survival \>3 months; 4. No prior anti-lymphoma treatment; 5. Signed written informed consent and ability to comply with protocol-required visits and procedures; 6. ECOG performance status 0-2; 7. Adequate organ and bone marrow function, defined as follows: * Hematology: Absolute neutrophil count (ANC) ≥1×10⁹/L, platelet count (PLT) ≥50×10⁹/L, hemoglobin (HGB) ≥8.0 g/dL; no granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 7 days prior to testing; * Hepatic function: Total 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: NYHA Class III or below; left ventricular ejection fraction ≥50% by echocardiography; * Coagulation: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤ULN +10s, and prothrombin time (PT) ≤ULN +3s; 8. 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: 1. Central nervous system involvement; 2. History of hypersensitivity to the study drug, drugs of the same class, or excipients; 3. Concurrent malignancy requiring treatment or intervention; 4. Major surgery within 4 weeks prior to treatment (excluding vascular access catheter placement or biopsy); 5. 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; 6. 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; 7. Active bleeding; 8. 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; 9. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome; 10. Exclusion of patients with active chronic hepatitis B or active hepatitis C. Patients with positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening must undergo further HBV-DNA and HCV-RNA testing. Patients with stable hepatitis B (HBV-DNA \<2500 copies/mL or 500 IU/mL) on antiviral therapy and cured hepatitis C patients (below the limit of detection) may be enrolled; 11. Definitive history of neurological or psychiatric disorder, including epilepsy or dementia; 12. Pregnant or lactating women; 13. Receipt of other investigational agents within 1 month prior to first dose; 14. Any other factors that, in the investigator's opinion, may affect the evaluation of efficacy or safety in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jiangsu Province Hospital The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
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