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

NCT07448324 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-04

No results posted yet for this study

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).

Conditions

  • Marginal Zone Lymphoma(MZL)

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2028-01-01
Completion
2030-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07448324 on ClinicalTrials.gov