DLBCL - Diffuse Large B Cell LymphomaPhase 2NCT07744737
Pirtobrutinib + R-CHOP for Untreated Non-GCB DLBCL
A Phase 2 study testing Pirtobrutinib plus R-CHOP in people with DLBCL - Diffuse Large B Cell Lymphoma and R-CHOP Chemotherapy, run by Changzhou No.2 People's Hospital at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma, R-CHOP Chemotherapy, Pirtobrutinib
- What is being tested?
- Pirtobrutinib plus R-CHOP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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;
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- 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.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
- 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.
- Confirmed prior history of neurological or psychiatric disorders, including epilepsy or dementia;
- Pregnant or lactating women;
- Received any other investigational product within 1 month prior to the first dose;
- Other conditions that, in the Investigator's judgment, may interfere with the evaluation of efficacy or safety of the study treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jianyong Li, PhD contact
China1 site
Jiangsu Province Hospital The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Jianyong Li
About this study
Official title: A Prospective, Multicenter Clinical Study of Pirtobrutinib Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) for the Treatment of Previously Untreated Non-GCB DLBCL
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)
- Being tested
- Pirtobrutinib plus R-CHOP
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirtobrutinib plus R-CHOPDrug
The treatment regimen consists of pirtobrutinib 200 mg orally on days 1-21 of each 21-day cycle for 6 cycles, combined with R-CHOP given as follows: rituximab 375 mg/m² intravenously on day 1; cyclophosphamide 750 mg/m² intravenously on day 2; doxorubicin 50 mg/m² intravenously on day 2; vincristine 1.4 mg/m² (maximum 2 mg) intravenously on day 2 for 6 cycles; and prednisone 100 mg orally on days 1-5 of each 21-day cycle for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pirtobrutinib+R-CHOP for newly diagnosed non GCB DLBCL | Experimental | This single-arm, open-label, multicenter study evaluates pirtobrutinib plus R-CHOP in untreated Non-GCB DLBCL. PET/CT is performed after 3 cycles; CR/PR patients continue for 3 more cycles, while PD/SD patients discontinue. Post-6-cycle CR/PR patients proceed to autologous HSCT if eligible, or pirtobrutinib maintenance (200 mg qd) for 6 months otherwise. Follow-up includes PET/CT or contrast-enhanced CT every 3 months in Year 1 and every 6 months thereafter until progression, death, consent withdrawal, or study end, whichever comes first. Receives: Drug: Pirtobrutinib plus R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR) after 6 cycles of induction therapy
Measured: week 18，at the end of 6 cycles of induction therapy（each cycle is 21 days）
Secondary outcomes (4)
Objective Response Rate (ORR) after 6 cycles of induction therapy
Measured: week 18，at the end of induction therapy(each cycle is 21 days)
Overall Survival (OS)
Measured: up to 3 years
Progression-Free Survival(PFS)
Measured: up to 3 years
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou No.2 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Xuzhang, Changzhou No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744737
- Sponsor's protocol ID
- 2026CELH026-01
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study of Pirtobrutinib Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) for the Treatment of Previously Untreated Non-GCB DLBCL
- ClinicalTrials.gov ID
- NCT07744737
- Acronym / sponsor ID
- 2026CELH026-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Changzhou No.2 People's HospitalUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pirtobrutinib+R-CHOP for newly diagnosed non GCB DLBCL | Experimental | Drug: Pirtobrutinib plus R-CHOPThis single-arm, open-label, multicenter study evaluates pirtobrutinib plus R-CHOP in untreated Non-GCB DLBCL. PET/CT is performed after 3 cycles; CR/PR patients continue for 3 more cycles, while PD/SD patients discontinue. Post-6-cycle CR/PR patients proceed to autologous HSCT if eligible, or pirtobrutinib maintenance (200 mg qd) for 6 months otherwise. Follow-up includes PET/CT or contrast-enhanced CT every 3 months in Year 1 and every 6 months thereafter until progression, death, consent withdrawal, or study end, whichever comes first. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirtobrutinib plus R-CHOPThe treatment regimen consists of pirtobrutinib 200 mg orally on days 1-21 of each 21-day cycle for 6 cycles, combined with R-CHOP given as follows: rituximab 375 mg/m² intravenously on day 1; cyclophosphamide 750 mg/m² intravenously on day 2; doxorubicin 50 mg/m² intravenously on day 2; vincristine 1.4 mg/m² (maximum 2 mg) intravenously on day 2 for 6 cycles; and prednisone 100 mg orally on days 1-5 of each 21-day cycle for 6 cycles. | Drug | Pirtobrutinib+R-CHOP for newly diagnosed non GCB DLBCL |
Primary outcome
Complete Response Rate (CRR) after 6 cycles of induction therapy
Time frame: week 18，at the end of 6 cycles of induction therapy（each cycle is 21 days）
4 secondary outcomes
Objective Response Rate (ORR) after 6 cycles of induction therapy
Time frame: week 18，at the end of induction therapy(each cycle is 21 days)
Overall Survival (OS)
Time frame: up to 3 years
Progression-Free Survival(PFS)
Time frame: up to 3 years
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianyong Li, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirtobrutinib plus R-CHOP in people with DLBCL - Diffuse Large B Cell Lymphoma and R-CHOP Chemotherapy, run by Changzhou No.2 People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianyong Li, PhD (lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CRR) after 6 cycles of induction therapy (time frame: week 18，at the end of 6 cycles of induction therapy（each cycle is 21 days）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.