Pirtobrutinib + R-CHOP for Untreated Non-GCB DLBCL: A Prospective, Multicenter Study

NCT07744737 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026CELH026-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

DLBCL - Diffuse Large B Cell Lymphoma; R-CHOP Chemotherapy; Pirtobrutinib

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR) after 6 cycles of induction therapy

  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

  week 18，at the end of induction therapy(each cycle is 21 days)

• Overall Survival (OS)

  up to 3 years

• Progression-Free Survival(PFS)

  up to 3 years

• Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0

  up to 3 years

Study Arms (1)

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.

Drug: Pirtobrutinib plus R-CHOP

Interventions

Pirtobrutinib plus R-CHOP DRUG

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.

Pirtobrutinib+R-CHOP for newly diagnosed non GCB DLBCL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Changzhou No.2 People's Hospital: lead

Study Sites (1)

Jiangsu Province Hospital The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Interventions

pirtobrutinib

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jianyong Li, PhD

CONTACT

lijianyonglm@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): April 30, 2029
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

CN (1)