Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07448324

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-03-04

50

Participants Needed

1

Research Sites

248 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older, any gender
  • Histologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, or NMZL with at least one measurable lesion
  • Stage III or IV disease requiring treatment
  • No prior systemic therapy, though prior local treatments allowed if followed by progression or relapse
  • ECOG performance status between 0 and 2
  • Adequate organ function including specific blood count and blood chemistry levels
  • Coagulation status with INR less than or equal to 1.5 times upper limit of normal
  • Expected survival of at least 12 months
  • Provided voluntary written informed consent before screening
Not Eligible

You will not qualify if you...

  • Current or past other malignancies unless disease-free for 5 years after curative treatment
  • Central nervous system involvement or transformation to high-grade lymphoma
  • Uncontrolled or significant cardiovascular diseases including NYHA Class II or higher heart failure, recent myocardial infarction, arrhythmias, primary cardiomyopathy, significant QTc prolongation, symptomatic coronary artery disease, or poorly controlled hypertension
  • Active bleeding within 2 months before screening or current use of anticoagulants
  • History of deep vein thrombosis or pulmonary embolism within 6 months
  • History of organ or bone marrow transplantation
  • Major surgery within 6 weeks or minor surgery within 2 weeks before screening
  • Active infection or uncontrolled hepatitis B or C, HIV/AIDS, or other serious infections
  • Severe pulmonary conditions impairing lung function
  • Prior treatment with BTK inhibitors, BCR pathway inhibitors, or BCL-2 inhibitors
  • Pregnancy, breastfeeding, or unwillingness to use effective contraception if of childbearing potential
  • Use of moderate/strong CYP3A inhibitors or strong inducers
  • Any other condition deemed unsuitable by the investigator for trial participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

L

Lei Fan, PhD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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