NCT04998669

Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma

Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Juan P. Alderuccio, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Loncastuximab tesirine	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.
DRUG	Rituximab	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.

Timeline

• Start date: 2022-02-11
• Primary completion: 2027-08-01
• Completion: 2030-08-01
• First posted: 2021-08-10
• Last updated: 2026-03-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study