Combining zanubrutinib with R-CHOP for treating newly diagnosed Non-GCB DLBCL

Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL

This study is testing if adding zanubrutinib to the standard R-CHOP treatment can help people with newly diagnosed Non-GCB diffuse large B-cell lymphoma feel better and improve their chances of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: zanubrutinib
• Locations: 16 sites (Hefei, Anhui and 15 other locations)
• Trial ID: NCT04835870 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of zanubrutinib, a Bruton's tyrosine kinase inhibitor, in combination with the standard R-CHOP regimen for patients with newly diagnosed untreated Non-GCB diffuse large B-cell lymphoma (DLBCL). Non-GCB DLBCL is associated with poorer clinical outcomes, and this trial aims to improve treatment responses. Participants will receive zanubrutinib along with rituximab, cyclophosphamide, doxorubicin, and vincristine. The study will assess both the effectiveness of this combination therapy and its safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed Non-GCB DLBCL and measurable disease.

Not a fit: Patients with primary mediastinal lymphoma, primary CNS lymphoma, or a history of indolent lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with Non-GCB DLBCL.

How similar studies have performed: While the use of BTK inhibitors in B-cell malignancies has shown promise, this specific combination approach is novel and has not been extensively tested.

Eligibility 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.

Where this trial is running

Hefei, Anhui and 15 other locations

• The First Affiliated Hospital of USTC Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (Recruiting)
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)
• Nantong Tumor Hospital — Nantong, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Changshu No.1 People's Hospital — Suzhou, Jiangsu, China (Recruiting)
• Suzhou Hongci Hematology Hospital — Suzhou, Jiangsu, China (Recruiting)
• Zhangjiagang First Peoples Hospital — Suzhou, Jiangsu, China (Recruiting)
• Affiliated Hospital Of Jiangnan University — Wuxi, Jiangsu, China (Recruiting)
• Wuxi People's Hospital — Wuxi, Jiangsu, China (Recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Recruiting)
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Caixia Li, M.D

Conditions Non-GCB/ABC Diffuse Large B-Cell Lymphoma; Zanubrutinib, R-CHOP, Newly diagnosed Non-GCB DLBCL