Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
- Conditions
- Non-GCB/ABC Diffuse Large B-Cell Lymphoma
- Interventions
- Registration Number
- NCT04835870
- Lead Sponsor
- The First Affiliated Hospital of Soochow University
- 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-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. This study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R-CHOP + Zanubrutinib Rituximab Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) R-CHOP + Zanubrutinib Vincristine Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) R-CHOP + Zanubrutinib Zanubrutinib Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) R-CHOP + Zanubrutinib Cyclophosphamide Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) R-CHOP + Zanubrutinib Doxorubicin Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) R-CHOP + Zanubrutinib Prednisone Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
- Primary Outcome Measures
Name Time Method Progression-free Survival(PFS) up to 18 months To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) up to 18 months To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
Complete Response Rate up to 18 months Number of patients who achieved complete response after treatment by ZR-CHOP
Duration of Response up to 18 months Duration of overall response will be assessed from the first ZR-CHOP given to progression,death or last follow-up.
Overall Survival up to 18 months OS will be assessed from the first ZR-CHOP given to death or last follow-up.
Adverse events profile Measured from start of treatment until 28 days after last dose Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated
Trial Locations
- Locations (16)
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Zhangjiagang First Peoples Hospital
🇨🇳Suzhou, Jiangsu, China
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
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
Suzhou Hongci Hematology Hospital
🇨🇳Suzhou, Jiangsu, China
Affiliated Hospital Of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
Changshu No.1 People's Hospital
🇨🇳Suzhou, 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