UnknownPhase 2

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

China78 participantsStarted 2021-04-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically confirmed Non-GCB DLBCL with extrinsic involvement
✓. Age ≥ 18 years
✓. Measurable disease of at least 15mm(node)/10mm（extranodal）
✓. ECOG performance status 0-2
✓. 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
✓. Adequate bone marrow function:Platelet count (≥ 50×10\^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10\^9/L)
✓. Estimated survival time ≥3 months
✓. 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

✕. Accepted major surgery within 4 weeks before treatment;
✕. Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
✕. Previous history of indolent lymphoma;
✕. 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;
✕. History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
✕. Requires treatment with a strong/medium CYP3A inducer;
✕. The previous use of anthracycline-based drugs \> 150 mg/m2;
✕. 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;

What they're measuring

Progression-free Survival(PFS)

Timeframe: up to 18 months

Trial details

NCT IDNCT04835870

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

Contact for this trial

Caixia Li, M.D

+86 512 67781856 licaixia@suda.edu.cn

View on ClinicalTrials.gov More Non-GCB/ABC Diffuse Large B-Cell Lymphoma trials