Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Apr 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new treatment called zanubrutinib when combined with standard chemotherapy (R-CHOP) for patients who have been newly diagnosed with a specific type of lymphoma known as Non-GCB Diffuse Large B-Cell Lymphoma (DLBCL). The goal is to see if this combination can help improve treatment outcomes for patients who have not yet received any treatment for their cancer.

To be eligible for this study, participants must be at least 18 years old and have a confirmed diagnosis of Non-GCB DLBCL with measurable disease. They should also have a good overall health status, with certain blood tests showing they can tolerate the treatment. Patients who have had recent major surgeries, certain other types of lymphoma, or specific health issues might not qualify. If someone joins the trial, they can expect to receive the new treatment and will be closely monitored for its effects and any potential side effects. This study is currently recruiting participants, so those interested should discuss it with their healthcare provider to see if they qualify.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed Non-GCB DLBCL with extrinsic involvement
• • 2. Age ≥ 18 years
• • 3. Measurable disease of at least 15mm(node)/10mm（extranodal）
• • 4. ECOG performance status 0-2
• • 5. Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN
• • 6. Adequate bone marrow function:Platelet count (≥ 50×10\^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10\^9/L)
• • 7. Estimated survival time ≥3 months
• • 8. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study
• Exclusion Criteria:
• • 1. Accepted major surgery within 4 weeks before treatment;
• • 2. Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
• • 3. Previous history of indolent lymphoma;
• • 4. Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
• • 5. History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
• • 6. Requires treatment with a strong/medium CYP3A inducer;
• • 7. The previous use of anthracycline-based drugs \> 150 mg/m2;
• • 8. Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease;
• • 9. HIV infection and/or active hepatitis B or active hepatitis C;
• • 10. Uncontrolled systemic infection;
• • 11. Pregnant or breasting-feeding women;
• • 12. According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.