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

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 11, 2022

Primary Completion Date

August 1, 2027

Study Completion Date

August 1, 2030

Conditions
Follicular Lymphoma
Interventions
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."

Trial Locations (5)

15212

NOT_YET_RECRUITING

Allegheny Health Network, Pittsburgh

33136

RECRUITING

University of Miami, Miami

33916

NOT_YET_RECRUITING

Florida Cancer Specialists and Research Institute, Fort Myers

48109

NOT_YET_RECRUITING

University of Michigan, Ann Arbor

08901

NOT_YET_RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ADC Therapeutics S.A.

INDUSTRY

lead

Juan P. Alderuccio, MD

OTHER