New hope for aggressive lymphoma: targeted drug combo enters trial
NCT ID NCT06005870
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether adding zanubrutinib to standard chemotherapy (R-CHOP) can better treat newly diagnosed diffuse large B-cell lymphoma that shows p53 protein expression. About 41 adults aged 18–75 will receive the combination. The main goal is to see how many patients achieve complete remission, with secondary aims of overall survival and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zanubrutinib combined with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)
- What this could lead to
- If successful, this combination could improve complete response rates and long-term outcomes for a hard-to-treat subtype of lymphoma with p53 expression.
- What could go wrong
- This is a small Phase 2 trial with only 41 participants, so results may not apply broadly. Adding zanubrutinib to R-CHOP may increase side effects like infections or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430022, China
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