Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04989621

Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)

Led by Sun Yat-sen University · Updated on 2026-04-23

32

Participants Needed

3

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)

CONDITIONS

Official Title

Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed grade 1, 2, or 3A follicular lymphoma
  • Previous anti-lymphoma treatment received
  • At least one lesion that can be evaluated by 2014 Lugano criteria
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy greater than 3 months
  • Able to participate in all required study procedures
  • Proper functioning of major organs
Not Eligible

You will not qualify if you...

  • Use of warfarin or history of stroke or brain bleeding within 6 months
  • Active transformed follicular lymphoma or known central nervous system lymphoma
  • Prior allogeneic hematopoietic stem cell transplant (prior autologous transplant allowed)
  • Previous treatment with ibrutinib or other BTK inhibitors
  • Uncontrolled active infection except tumor-related fever
  • Recent treatments: nitrosoureas within 6 weeks, chemotherapy within 3 weeks, anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or investigational agents within 3 weeks, or major surgery within 4 weeks before study drug
  • Progressed or refractory while on PI3K inhibitors (except those who stopped due to toxicity while responding)
  • Need for strong CYP3A inhibitors
  • Significant heart disease such as uncontrolled arrhythmias, heart failure, or heart attack within 6 months
  • Active hepatitis B or C infection; certain hepatitis B or C statuses require further testing and approval

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Guangdong General Hospital

Guangzhou, Guangdong, China, 510000

Actively Recruiting

2

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,

Guangzhou, Guangdong, China, 51000

Not Yet Recruiting

3

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,

Guangzhou, Guangdong, China, 51000

Actively Recruiting

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Research Team

Q

Qingqing Cai

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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Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL) | DecenTrialz