Zanubrutinib combined with R-CHOP for treating newly diagnosed DLBCL with p53 expression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of zanubrutinib in combination with R-CHOP for patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL) who have p53 protein expression of 50% or more. It is a prospective, single-arm, single-center study that aims to recruit 41 patients. The study follows a two-phase design, where the first phase requires at least 12 patients to achieve a complete response to proceed to the second phase. Participants will receive 6 cycles of treatment, with interim assessments to evaluate their response after 4 cycles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years, ≤ 75 years, both sexes;
2. Diff use large B-cell lymphoma diagnosed by histopathology without previous systemic DLBCL treatment;
3. ECOG score: 0-2;
4. Predicted survival ≥3 months;
5. Patients with positive p53 expression detected by immunohistochemistry (≥50% );
6. 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.

1. 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.
2. Patients volunteered to participate in the trial, understood the study procedure, and were able to sign in-person informed consent.

Exclusion Criteria:

1. Patients with definite lymphoma central nervous system (CNS) infiltration, including brain parenchyma, meningeal invasion, or spinal cord compression;
2. severe or uncontrolled infection;
3. with active autoimmune disease;
4. Other serious medical conditions, such as uncontrolled diabetes, gastric ulcers, other serious cardiopulmonary diseases, etc. (the decision was left to the investigator);
5. 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;
6. The subject has previous or co -e xis ting other malignant tumors; Patients with basal cell carcinoma of the skin and uterine and neck carcinoma in situ who had been cured for more than 3 years, and patients with other malignant tumors who had been cured for more than 5 years were considered for inclusion.
7. HIV-positive patients with active hepatitis B ( HBV-DNA \> 100 copies/m L), positive HCV antibody, or abnormal HCV-RNA
8. 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;
9. were allergic to any of the drugs in the study protocol;
10. ineligible for inclusion as judged by the investigator ;

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Liling Zhang, M.D
• Email: lily1228@sina.com
• Phone: 0086 27 83262660

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL

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  Recruiting Phase 2 Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07012980

• Zanubrutinib with R-CHOP for DLBCL that has MYD88, CD79B, NOTCH1 changes, or is CD5+

  This study will try adding zanubrutinib to standard R-CHOP chemotherapy for adults with DLBCL who have an MYD88 L265P, CD79B, or NOTCH1 truncation mutation, or who are CD5+ by IHC.

  Recruiting Phase 2 Virginia Commonwealth University · Richmond, Virginia · NCT06846463

• Comparing Pola-ZR2 and ZR2 for treating elderly patients with diffuse large B-cell lymphoma

  This study is testing if adding a new drug called polatuzumab vedotin to a standard treatment helps older patients with diffuse large B-cell lymphoma feel better and improve their outcomes.

  Recruiting Phase 3 Ruijin Hospital · Shanghai · NCT06522555

• Using zanubrutinib and lenalidomide for maintenance in lymphoma patients

  This study is testing whether the combination of zanubrutinib and lenalidomide can help people with diffuse large B-cell lymphoma stay in remission after chemotherapy.

  Recruiting Phase 2 Navy General Hospital, Beijing · Beijing, Beijing Municipality · NCT06503263

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Zanubrutinib plus Lenalidomide for frail elderly with newly diagnosed PCNSL

  This study tests whether a combination of zanubrutinib and lenalidomide can help frail elderly patients with newly diagnosed primary CNS lymphoma.

  Recruiting Phase 2 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07839247

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.