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NOT YET RECRUITING
NCT07008053
PHASE2

BR Combined With OR in Treatment-naïve Marginal Zone Lymphoma

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2025-07

Completion Date

2028-11

Last Updated

2025-06-06

Healthy Volunteers

No

Interventions

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.

Locations (6)

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China