Zanubrutinib Combined With R-CHOP in the Treatment of Newly Diagnosed DLBCL With p53 Protein Expression

NCT06005870 | Recruiting Phase 2

• 1 other identifier: UHCT22242
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to evaluate the efficacy and safety of zanubrutinib combined with R-CHOP in the treatment of DLBCL patients with p53 protein expression.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

DLBCL; Diffuse Large b-cell lymphoma; p53; zanubrutinib

Outcome Measures

Primary Outcomes (1)

• Complete response rate (CRR)

  To evaluate the efficacy of anti-lymphoma

  At the end of cycle 6 (each cycle is 21 days )

Secondary Outcomes (4)

• Overall response rate (ORR)

  At the end of cycle 6 (each cycle is 21 days )

• Progression-free survival (PFS)

  From date of initiation therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

• Overall survival (OS)

  From date of initiation therapy until the date of death from any cause, assessed up to 60 months

• Rate of AE and SAE

  from the initiation of the first dose to 28 days after the last dose

Study Arms (1)

Z-RCHOP

EXPERIMENTAL

Patients with newly diagnosed DLBCL with p53 expression were treated with a combination of Zanubrutinib and RCHOP.

Drug: Zanubrutinib plus RCHOP

Interventions

Zanubrutinib plus RCHOP DRUG

Rituximab 375mg/m2 D1; cyclophosphamide 750mg/m2 D2; adriamycin 50 mg/m2 D2 vincristine 1.4mg/m(Max 2mg) D2; prednisone 100mg/d D2-6; Zanubrutinib 160 mg, bid D1-21

Z-RCHOP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, ≤ 75 years, both sexes;
• Diff use large B-cell lymphoma diagnosed by histopathology without previous systemic DLBCL treatment;
• ECOG score: 0-2;
• Predicted survival ≥3 months;
• Patients with positive p53 expression detected by immunohistochemistry (≥50% );
• The patients had certain conditions of organ function reserve, and the laboratory tests within 1 week before enrollment met the following conditions:
• Blood routine: neutrophil count (NEUT) ≥1.5×10\^9/L, platelet count (PLT)
• ≥75×10\^9/L, hemoglobin (HGB) ≥80 g/L; G-CSF was not used in the past 7 days (the researchers judged that the lymphoma-induced cytopenia could be included).
• Liver function: Total bilirubin (TBIL) ≤1.5× upper limit of the normal range (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; If liver metastases were present, TBIL≤3×ULN, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤2.0×ULN or creatinine clearance (CCr) ≥60ml/min;
• Cardiac function: LVEF≥50%, ECG did not indicate any acute myocardial infarction, arrhythmia, or atrioventricular conduction block above grade I;
• Thyroid function: thyroid stimulating hormone (TSH) was within the normal range. If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) should be within the normal range or abnormal without clinical significance.
• According to the Lugano2014 assessment criteria, patients must have measurable lesions, defined as the longest diameter of at least one nodule \> 1.5cm, or the longest diameter of at least one nodule \> 1cm, and at least two vertical diameters that can be accurately measured.
• Patients volunteered to participate in the trial, understood the study procedure, and were able to sign in-person informed consent.

You may not qualify if:

• Patients with definite lymphoma central nervous system (CNS) infiltration, including brain parenchyma, meningeal invasion, or spinal cord compression;
• severe or uncontrolled infection;
• with active autoimmune disease;
• Other serious medical conditions, such as uncontrolled diabetes, gastric ulcers, other serious cardiopulmonary diseases, etc. (the decision was left to the investigator);
• patients who received the live attenuated vaccine within 4 weeks before the first dose or planned to receive the live attenuated vaccine during the study;
• HIV-positive patients with active hepatitis B ( HBV-DNA \> 100 copies/m L), positive HCV antibody, or abnormal HCV-RNA
• Women who were pregnant or lactating, women who planned to become pregnant between the study period and 6 months after the last dose, or men whose partners planned to become pregnant, who were unwilling to use a medically approve defective contraceptive method (e.g., intrauterine device or condom ) during the trial;
• were allergic to any of the drugs in the study protocol;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Liling Zhang, M.D

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Liling Zhang, M.D

CONTACT

0086 27 83262660; lily1228@sina.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: Professor

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 23, 2023
• Study Start: November 26, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

CN (1)