Status:
UNKNOWN
Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Non-GCB/ABC Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Detailed Description
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germina...
Eligibility Criteria
Inclusion
- 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
- 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;
- HIV infection and/or active hepatitis B or active hepatitis C;
- Uncontrolled systemic infection;
- Pregnant or breasting-feeding women;
- According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04835870
Start Date
April 1 2021
End Date
October 1 2025
Last Update
September 16 2022
Active Locations (16)
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1
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
3
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
4
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China