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

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Juan P. Alderuccio, MD
Study ID
NCT04998669
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Loncastuximab tesirine — DRUG
    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.
  • Rituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 11, 2022
Status verified
Mar 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Loncastuximab tesirine + Rituximab
    During the 12-week Induction Phase (Cycles 1 to 4), participants will receive loncastuximab tesirine on days 1 of each 3-week cycle for Cycles 1 through 4; and rituximab on days 1, 8, 15 of Cycle 1 and day 1 of Cycle 2. Maintenance Phase 1 (Cycle 5) is 8 weeks: Participants achieving complete response (CR) or partial response (PR) during the Induction Phase will receive loncastuximab tesirine once every 3-weeks; and rituximab once during week 7 or 8. Participants achieving a response of Stable Disease (SD) or Progressive Disease (PD) will be taken off treatment. Maintenance Phase 2 (Cycles 6 and 7) is 16 weeks: * Participants achieving CR during Maintenance Phase 1 receive rituximab once during week 7 or 8 of Cycles 6 and 7. * Participants achieving PR during Maintenance Phase 1 receive loncastuximab tesirine once every 3-weeks over each 8 week cycle; and rituximab once during week 7 or 8 of Cycles 6 and 7. * Participants achieving SD or PD will be taken off treatment.

Primary Outcome Measure

Number of participants achieving Complete Response (CR) [ Time Frame: 12 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists and Research InstituteFort MyersFlorida33916
Chandni Patel
[email protected]
(561) 618-0383
Bradley J Monk, MD, FACS
[email protected]
(602) 300-0138
Bradley J Monk, MD, FACS (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Juan P Alderuccio, MD
[email protected]
305-243-5995
Juan P Alderuccio, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Yasmin H Karimi, MD
734-647-8902
Yasmin H Karimi, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Matt Matasar, MD
[email protected]
Matt Matasar, MD (PRINCIPAL_INVESTIGATOR)
Allegheny Health NetworkPittsburghPennsylvania15212
Marla Harris
[email protected]
Maggie Saunders
[email protected]
Cyrus Khan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Myers, FL

By research site
Florida Cancer Specialists and Research Institute· Fort Myers, FLUniversity of Miami· Miami, FLUniversity of Michigan· Ann Arbor, MIRutgers Cancer Institute of New Jersey· New Brunswick, NJAllegheny Health Network· Pittsburgh, PA

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