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RECRUITING
NCT07448324
PHASE2

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).

Official title: Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL#a Prospective Single Arm Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-04-01

Completion Date

2030-01-01

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orelabrutinib: 150mg qd C1-C6

DRUG

Rituximab

Rituximab: C1-C6

DRUG

Lenalidomide

After 6 cycles of orelabrutinib + rituximab CR: Continue orelabrutinib + rituximab for 6 cycles. PR/SD: Switch to orelabrutinib + rituximab + lenalidomide for 6 cycles. PD: Discontinue study treatment.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China