Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
NCT ID: NCT04835870
Last Updated: 2022-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
78 participants
INTERVENTIONAL
2021-04-01
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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R-CHOP + Zanubrutinib
Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Zanubrutinib
Zanubrutinib-160mg bid PO d0-d20(1-21d)
Rituximab
Rituximab-375 mg/m2 i.v d0 (/21d)
Cyclophosphamide
Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
Doxorubicin
Doxorubicin-50 mg/m2 i.v d1 (/21d)
Vincristine
Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
Prednisone
Prednisone-100 mg p.o d1-d5 (/21d)
Interventions
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Zanubrutinib
Zanubrutinib-160mg bid PO d0-d20(1-21d)
Rituximab
Rituximab-375 mg/m2 i.v d0 (/21d)
Cyclophosphamide
Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
Doxorubicin
Doxorubicin-50 mg/m2 i.v d1 (/21d)
Vincristine
Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
Prednisone
Prednisone-100 mg p.o d1-d5 (/21d)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Depei Wu, M.D
Role: STUDY_CHAIR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Changshu No.1 People's Hospital
Suzhou, Jiangsu, China
Suzhou Hongci Hematology Hospital
Suzhou, Jiangsu, China
Zhangjiagang First Peoples Hospital
Suzhou, Jiangsu, China
Affiliated Hospital Of Jiangnan University
Wuxi, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Caixia Li
Role: primary
References
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Geng H, Jia S, Zhang Y, Li J, Yang Q, Zeng L, Zong X, Lu Y, Lu S, Zhou J, Li C, Wu D. Efficacy and safety of zanubrutinib plus R-CHOP in treatment of non-GCB DLBCL with extranodal involvement. Front Immunol. 2023 Aug 21;14:1219167. doi: 10.3389/fimmu.2023.1219167. eCollection 2023.
Other Identifiers
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ZR-CHOP
Identifier Type: -
Identifier Source: org_study_id
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