Zanubrutinib Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma With p53 Protein Expression

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Liling Zhang, M.D
15871725926lily1228@sina.com
15871725926
Time Frame
Start Date: 2022-11-26
Estimated Completion Date: 2026-12
Participants
Target number of participants: 41
Treatments
Experimental: Z-RCHOP
Patients with newly diagnosed DLBCL with p53 expression were treated with a combination of Zanubrutinib and RCHOP.
Sponsors
Leads: Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov