Actively Recruiting
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
Eligibility Criteria
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
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
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
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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