NCT07008053

BR Combined With OR in Treatment-naïve Marginal Zone Lymphoma

BR (Bendamustine and Zuberitamab) Combined With OR (Orelabrutinib and Zuberitamab) in Treatment-naïve Marginal Zone Lymphoma: A Multicenter, Prospective Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of BR (bendamustine and zuberitamab) combined with OR (orelabrutinib and zuberitamab) in treatment-naïve patients with marginal zone lymphoma.

Detailed description

Marginal zone lymphoma (MZL) represents the second most prevalent indolent lymphoma subtype, accounting for 5-15% of all non-Hodgkin lymphomas. MZL is categorized into three subtypes based on distinct clinical and pathological features: mucosa-associated lymphoid tissue lymphoma (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL). Currently, there remains no internationally recognized consensus regarding the optimal first-line treatment for MZL. Exploring more effective, low-toxicity treatment regimens for MZL patients is a scientifically valuable and clinically significant attempt. Orelabrutinib, a novel highly selective BTK inhibitor, has been approved by the NMPA for the treatment of MZL in patients who have received at least one prior treatment. This study is a multi-center, prospective clinical study involving previously untreated MZL patients. During the induction therapy phase, patients will receive 90 mg/m2 of bendamustine and 375 mg/m2 zuberitamab from cycles 1 to 3, followed by 150 mg of orelabrutinib and 375 mg/m2 zuberitamab from cycles 4 to 6. At the investigator's discretion, patients who achieved a complete response or partial response could be assigned to maintenance therapy, consisting of 150 mg of orelabrutinib for up to 24 cycles.

Conditions

• Marginal Zone Lymphomas

Interventions

Type	Name	Description
DRUG	BR+OR	Patients who meet the inclusion criteria will enter the treatment period, which consists of an induction phase followed by a maintenance phase. During the induction treatment period, a combined treatment of 3 cycles of the BR regimen and 3 cycles of the OR regimen will be administered, every 28-day cycle for 6 cycles. After the induction treatment, the efficacy assessment will determine whether patients with CR or PR proceed to the maintenance treatment period. Orelabrutinib monotherapy will used as maintenance therapy, every 28-day cycle for up to 24 cycles, or until disease progression/recurrence, unacceptable toxicity, death or consent withdrawal.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2028-11-01
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

6 sites across 1 country: China