Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
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.
Arms & interventions
- DrugLoncastuximab 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.
- DrugRituximab
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.
Outcome measures
Primary
Number of participants achieving Complete Response (CR)
Complete Response rate will be reported as the number of participants achieving complete response (CR) to study therapy. Response to therapy will be assessed using Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) (FDG-PET)/ Computerized Tomography (CT) following Lugano 2014 criteria by week 12 of treatment.
Time frame: 12 weeks
Secondary
Number of participants achieving CR or PR
Time frame: Week 12
Incidence of Treatment-Related Adverse Events
Time frame: Up to 13 months
Progression-free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Eligibility criteria
Study locations (5)
Florida Cancer Specialists and Research Institute
Fort Myers, Florida, 33916
University of Miami
Miami, Florida, 33136
University of Michigan
Ann Arbor, Michigan, 48109
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
References
- Alderuccio JP, Alencar AJ, Schatz JH, Kuker RA, Pongas G, Reis IM, Lekakis LJ, Spiegel JY, Sandoval-Sus J, Beitinjaneh A, Stanchina MD, Trabolsi A, Lossos IS, Rosenblatt JD, Lessen DS, Moskowitz CH. Loncastuximab tesirine with rituximab in patients with relapsed or refractory follicular lymphoma: a single-centre, single-arm, phase 2 trial. Lancet Haematol. 2025 Jan;12(1):e23-e34. doi: 10.1016/S2352-3026(24)00345-4. Epub 2024 Dec 7.(PubMed)