NCT04989621 Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)
| NCT ID | NCT04989621 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Follicular Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2021-08-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed grade 1, 2, or 3A FL; * Patients received prior anti-lymphoma treatment; * At least one evaluable lesion according to 2014 Lugano criteria; * Age 18 years or older; * Eastern Cooperative Oncology Group (ECOG) of 0-2; * Life expectancy \> 3 months; * Able to participate in all required study procedures; * Proper functioning of the major organs: Exclusion Criteria: * Patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease; * Histological transformation of follicular lymphoma; * Known central nervous system lymphoma; * Received a prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed; * Subjects who have received prior treatment with ibrutinib, or other BTK inhibitors; * Uncontrolled active infection, with the exception of tumor-related B symptom fever; * Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug; * Subjects who progressed or become refractory while on treatment with PI3K inhibitors are excluded. However, subjects who were responding to PI3K inhibitors, but had treatment discontinued due to toxicity, are eligible; * Patients require treatment with strong CYP3A inhibitors; * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening; * Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
Contact & Investigator
Qingqing Cai
STUDY DIRECTOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT04989621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Follicular Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04989621 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04989621 currently recruiting?
Yes, NCT04989621 is actively recruiting participants. Contact the research team at caiqq@sysucc.org.cn for enrollment information.
Where is the NCT04989621 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China.
Who is sponsoring the NCT04989621 clinical trial?
NCT04989621 is sponsored by Sun Yat-sen University. The principal investigator is Qingqing Cai at Sun Yat-Sen University Cancer Center. The trial plans to enroll 32 participants.