At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically confirmed follicular lymphoma grade 1, 2, or 3A
- ✓CD19 expression documented after prior CD19-directed therapy
- ✓Relapsed or refractory FL with ≥1 prior systemic therapy line
- ✕FL grade 3B or transformed FL
- ✕≥6 prior lines of systemic immunochemotherapy
- ✕Clinically significant pleural effusions/ascites requiring drainage or causing dyspnea
- ✕Currently receiving other investigational agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
In Brief
A Phase 2 clinical trial evaluating Loncastuximab tesirine and Rituximab for Follicular Lymphoma. Currently recruiting, targeting 100 participants across 5 sites.
Detailed Summary
The purpose of this research is to see if Loncastuximab Tesirine in combination with Rituximab will result in higher complete response rate when given to treat follicular lymphoma.
Study Details
Timeline
Interventions
Induction Phase (Cycles 1 through 4): * 150 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 1 and 2. * 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 3 and 4. Maintenance Phase 1 (Cycle 5): For participants achieving CR or PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines). on Day 1 on Week 1, 4, 7 of a 8-week cycle. Maintenance Phase 2 (Cycle 6 \& 7): For participants achieving PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Day 1 on Week 1, 4, 7 of a 8-week cycle.
Induction Phase (Cycles 1 through 4): 375 mg/m2 rituximab on days 1, 8, 15 of cycle 1 and day 1 of cycle 2 via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase during Cycles 1 and 2, per discretion of treating physician. Rituximab will not be administered during Cycles 3 and 4. Maintenance Phase 1 (Cycle 5): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 1 of a 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician. Maintenance Phase 2 (Cycles 6 and 7): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 1 of each 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician.