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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; Vincristine; Zanubrutinib

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.