Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06082102

Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2025-09-15

324

Participants Needed

19

Research Sites

322 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma

CONDITIONS

Official Title

Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Confirmed diagnosis of B-cell non-Hodgkin lymphoma marginal zone lymphoma (splenic, nodal, or extra-nodal)
  • Prior systemic therapy including at least one anti-CD20 monoclonal antibody regimen with minimum 2 completed cycles for combination therapies or minimum 4 doses for monotherapy, unless disease progressed during treatment
  • Relapsed or refractory disease status
  • At least one measurable lesion confirmed by enhanced CT or MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Not Eligible

You will not qualify if you...

  • Received specified anti-tumor therapies within 2 weeks before starting study treatment
  • Received any other investigational product within 4 weeks before study treatment or currently in another clinical trial (except long-term follow-up after discontinuation)
  • Prior treatment with any Bruton tyrosine kinase (BTK) inhibitor
  • Refractory to lenalidomide plus rituximab (R2 regimen), defined as failure to achieve at least partial response after adequate R2 treatment or disease progression during or within 6 months after R2 therapy
  • Lymphoma involving the central nervous system or meningeal involvement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 19 locations

1

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Auhui, China, 233000

Actively Recruiting

2

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

3

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

4

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510055

Actively Recruiting

5

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China, 510120

Actively Recruiting

6

Henan Cancer Hospital

Zhengzhou, Henan, China, 450003

Actively Recruiting

7

Henan Provincial Peoples Hospital

Zhengzhou, Henan, China, 450003

Actively Recruiting

8

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

9

Hunan Cancer Hospital

Changsha, Hunan, China, 410000

Not Yet Recruiting

10

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

Actively Recruiting

11

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China, 330029

Actively Recruiting

12

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China, 116023

Actively Recruiting

13

The first Hospital of China Medical University

Shenyang, Liaoning, China, 110002

Actively Recruiting

14

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong, China, 266000

Not Yet Recruiting

15

Yantai Yuhuangding Hospital

Yantai, Shandong, China, 264099

Actively Recruiting

16

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200040

Actively Recruiting

17

The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)

Xi’an, Shanxi, China, 710004

Actively Recruiting

18

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Not Yet Recruiting

19

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

Loading map...

Research Team

A

Alexia Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here