Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors

Trial Title: Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors

NCT ID: NCT05887726

Condition: Diffuse Large B Cell Lymphoma

Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Prednisone
Cyclophosphamide
Rituximab
Vincristine
Epirubicin
Zanubrutinib

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Zanubrutinib
Description: Zanubrutinib 160mg bid p.o d0-d20(21-day cycles)
Arm group label: Zanubrutinib + R-CHOP

Intervention type: Drug
Intervention name: Rituximab
Description: Rituximab 375 mg/m2 i.v d0(21-day cycles)
Arm group label: Zanubrutinib + R-CHOP

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: Cyclophosphamide 750 mg/m2 i.v d1(21-day cycles)
Arm group label: Zanubrutinib + R-CHOP

Intervention type: Drug
Intervention name: Epirubicin
Description: Epirubicin 75 mg/m2 i.v d1 or liposome adriamycin 35mg/m2 i.v d1(21-day cycles)
Arm group label: Zanubrutinib + R-CHOP

Intervention type: Drug
Intervention name: Vincristine
Description: Vincristine 1.4 mg/m2 i.v d1 (2 mg max) (21-day cycles)
Arm group label: Zanubrutinib + R-CHOP

Intervention type: Drug
Intervention name: Prednisone
Description: Prednisone 100 mg p.o d1-d5 (21-day cycles)
Arm group label: Zanubrutinib + R-CHOP

Summary: This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Histologically confirmed DLBCL patients have one of the following risk factors(including but not limited to double expression, extranodal involvement, high ki67, bulky)； 2. Age ≥ 18 years old; 3. At least one measurable lesion (defined as lymph node lesion ≥15mm, extra-segmental lesions ≥ 10mm); 4. ECOG performance status 0-2; 5. Functions of major organs meet the following conditions: Echocardiography left ventricular ejection fraction ≥50%; Creatinine clearance ≥30 ml/min; ALT and AST≤3 times the normal range； 6. Hematopoietic function should meet the following conditions: Platelet count ≥50×109/L; Hemoglobin ≥ 8.0g /dL; Absolute count of neutrophil (ANC)≥1.0×109/L; 7. Expected survival of ≧3 months Exclusion Criteria: 1. Major surgery within 4 weeks before treatment; 2. Severe organ dysfunction(including but not limited to complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases); 3. Patients who cannot cooperate with treatment or follow-up on time. 4. Pregnant or lactating females; 5. any uncontrolled active systemic infection requiring intravenous (IV) antibiotics; 6. There was a history of other active malignant diseases within the 2 years prior to study entry, except for: (1) adequately treated cervical carcinoma in situ; (2) local skin basal cell carcinoma or squamous cell carcinoma; (3) previous malignant disease that is under control and has undergone local radical treatment (surgical or other forms). 7. History of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von Willebrand's disease, or spontaneous bleeding requiring blood transfusion or other medical intervention 8. Human immunodeficiency virus (HIV) infection or the following serological status reflecting the presence of active hepatitis B or C virus infection: a. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) are present. Patients who are HBCAB-positive, HBsAg negative, have no hepatitis b virus (HBV) DNA (< 20 IU/mL), and agree to be monitored for HBV virus reactivation can be enrolled. Antibodies to the hepatitis C virus (HCV) are present. HCV antibody-positive patients with no HCV RNA detected could be included in the group. 9. The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the subject's safety or pose a risk to the study. 10. The researchers think it is not suitable to participate in this experiment.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Xing Xiaojing

Address:
City: Shenyang
Zip: 110000
Country: China

Start date: August 1, 2023

Completion date: August 1, 2025

Lead sponsor:
Agency: Liaoning Tumor Hospital & Institute
Agency class: Other

Source: Liaoning Tumor Hospital & Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05887726