NCT05596097

Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission

Clinical Research for Efficacy and Safety of Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: LanZhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single-center, single-arm, prospective clinical study to investigate the efficacy and safety of zanubrutinib maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) in Initial remission. The patients were divided into two categories: 1) Zanubrutinib maintenance therapy was started after R-CHOP induction and consolidation therapy reached maximum efficacy; 2) Initiate zanubrutinib maintenance therapy after maximal response to induction and consolidation therapy with or without rituximab (R-chemo). Therefore, the data in this study will reflect the efficacy and safety of zanubrutinib in the maintenance treatment of DLBCL patients with initial remission, and will provide new insights into the clinical application of zanubrutinib.

Detailed description

Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive malignant lymphoma, and because it is sensitive to chemotherapy, approximately 50% to 70% of patients can achieve a cure after first-line treatment. However, in recent years, it has been found that more than 30% of patients experience relapse within two years after first-line treatment, which is a serious health threat and requires urgent secondary treatment. To reduce the recurrence of DLBCL and improve the survival rate of patients, clinical researchers have long been dedicated to the maintenance treatment of DLBCL patients after first-line treatment, aiming to kill tumor cells and reduce the risk of recurrence through continuous drug administration, thus enabling patients to survive with the tumor for a long time. Several clinical trials are currently underway with rituximab, ibrutinib, lenalidomide, and thalidomide, but safer and more effective maintenance regimens have yet to be identified. Zanubrutinib, a new-generation BTK inhibitor, is the first anti-tumor drug developed locally in China and approved for marketing in the US. Zanubrutinib inhibits the activation of the BCR signaling pathway by specifically binding to cysteine residues at the active site of BTK to form a covalent bond that irreversibly inactivates them, thereby inhibiting BTK and improving the tumor microenvironment, inhibiting malignant proliferation and inducing apoptosis in tumor B cells. Several clinical studies have demonstrated that ibrutinib alone and in combination is no less effective than ibrutinib in the treatment of DLBCL, and has a better safety and tolerability profile. This study proposes to use Zanubrutinib for maintenance treatment in DLBCL patients in remission after primary treatment and to evaluate the efficacy and safety of patients to provide new insights into the clinical use of Zanubrutinib.

Conditions

• Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Zanubrutinib, 180mg, bid, p.o., d1-28; Treatment cycles every 28 days

Timeline

• Start date: 2022-10-30
• Primary completion: 2024-10-20
• Completion: 2026-07-30
• First posted: 2022-10-27
• Last updated: 2022-10-27

Locations

1 site across 1 country: China