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 |
Trial Parameters
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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