RecruitingPhase 2NCT04998669

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

Sponsor

Juan P. Alderuccio, MD

Enrollment

100 participants

Start Date

Feb 11, 2022

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of loncastuximab tesirine (an antibody-drug conjugate targeting CD19) and rituximab (a standard lymphoma antibody) in patients with follicular lymphoma — a slow-growing blood cancer — that has returned or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older with confirmed follicular lymphoma (grade 1, 2, or 3A) - Your lymphoma has relapsed or is no longer responding after at least 1 prior treatment - You have at least one of several specific signs of active disease (large lymph nodes, B-symptoms, or organ compression risk) - OR your disease progressed within 24 months of first-line treatment, or this is your second relapse - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have grade 3B follicular lymphoma or transformed lymphoma - You have had 6 or more prior lines of treatment - You have active HIV, or active hepatitis B or C - You have known brain involvement of lymphoma - You have significant pleural fluid accumulation, heart failure, recent heart attack, or stroke in the last 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.