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BR Combined With OR in Treatment-naïve Marginal Zone Lymphoma

NCT07008053 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-06-06

No results posted yet for this study

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.

Conditions

  • Marginal Zone Lymphomas

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Huilai Zhang · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-07-31
Completion
2028-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008053 on ClinicalTrials.gov