Can a targeted drug boost standard chemo for aggressive lymphoma?
NCT ID NCT07744737
First seen Aug 04, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This trial is testing whether adding pirtobrutinib, a targeted drug, to the standard R-CHOP chemotherapy regimen can improve outcomes for people with a specific subtype of diffuse large B-cell lymphoma (non-GCB DLBCL). The study will enroll about 34 adults with newly diagnosed disease who have not received prior treatment. Participants will receive pirtobrutinib alongside R-CHOP for six cycles, and researchers will measure how many achieve a complete response, along with safety and survival outcomes.
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 R-CHOP chemotherapy
- 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 remission rates and long-term outcomes.
- What could go wrong
- This is a small phase 2 study, so results may not be definitive. Adding pirtobrutinib to standard chemo could increase side effects, and the benefit over standard R-CHOP alone is not yet proven.
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 34 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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Apr 2029
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 80 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. Histopathologically confirmed non-GCB diffuse large B-cell lymphoma (DLBCL) (per the 2016 WHO diagnostic criteria); 2. Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per the 2014 Lugano Criteria); 3. Age 18-80 years, with estimated survival \> 3 months; 4. No prior anti-lymphoma treatment; 5. Able to provide written informed consent and comply with scheduled study visits and required procedures specified in the protocol; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 7. 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. 8. 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: 1. Central nervous system involvement; 2. History of hypersensitivity to the study drug, similar agents, or excipients; 3. Concurrent other malignancies requiring treatment or intervention; 4. Major surgical procedure performed within 4 weeks prior to treatment (excluding vascular access catheterization or biopsy); 5. Any life-threatening disease, medical condition, or organ dysfunction that, in the Investigator's opinion, may compromise patient safety or adherence to study procedures; 6. 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; 7. Patients with active bleeding; 8. 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. 9. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS). 10. Patients with active chronic hepatitis B or active hepatitis C are excluded.Patients positive for hepatitis B surface antigen, hepatitis B core antibody or hepatitis C virus antibody during screening must undergo further testing for HBV-DNA and HCV-RNA. Patients with stable hepatitis B after antiviral therapy (HBV-DNA \< 2500 copies/mL or 500 IU/mL) and cured hepatitis C patients (HCV-RNA below the lower limit of detection) are eligible for enrollment. 11. Confirmed prior history of neurological or psychiatric disorders, including epilepsy or dementia; 12. Pregnant or lactating women; 13. Received any other investigational product within 1 month prior to the first dose; 14. Other conditions that, in the Investigator's judgment, may interfere with the evaluation of efficacy or safety of the study treatment.
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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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