Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in La Jolla, California.

Sponsor
ADC Therapeutics S.A.
Study ID
NCT04384484
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Refractory Diffuse Large B-Cell Lymphoma
  • Relapsed Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Loncastuximab Tesirine — DRUG
    Intravenous Infusion
  • Rituximab — DRUG
    Intravenous Infusion
  • Gemcitabine — DRUG
    Intravenous Infusion
  • Oxaliplatin — DRUG
    Intravenous Infusion

Study Details

The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.

Key Dates

Start date
Sep 16, 2020
Status verified
Apr 2026
Primary completion
Mar 31, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
440 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)
    Part 1 consists of a non-randomized safety run-in period evaluating the study drug for the first 20 participants. Participants will receive Lonca-R on Day 1 of each cycle for up to 8 cycles, where 1 cycle is 3 weeks. Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m\^2 Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m\^2 Q3W for up to 6 additional cycles.
  • Experimental: Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)
    Randomized participants will receive Lonca-R on Day 1 of each cycle for up to 8 cycles, where 1 cycle is 3 weeks. Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m\^2 every Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m\^2 Q3W for up to 6 additional cycles.
  • Active Comparator: Part 2: Standard Immunochemotherapy (R-GemOx)
    Randomized participants will receive R-GemOx consisting of rituximab, gemcitabine and oxaliplatin as a standard immunochemotherapy treatment on Day 1 or Day 2 of each cycle for up to 8 cycles, where 1 Cycle is 2 weeks. R-GemOx will be administered via an intravenous infusion of rituximab 375 mg/m\^2 + gemcitabine 1000 mg/m\^2 + oxaliplatin 100 mg/m\^2 every 2 weeks (Q2W) for up to 8 cycles.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 4 years ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California San Diego Moores Cancer CenterLa JollaCalifornia92093-
Redlands Community HospitalRedlandsCalifornia92373-
The Oncology Institute of Hope and InnovationWhittierCalifornia90603-
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207-
UnityPoint Health - Iowa Oncology Research Association (IORA)Des MoinesIowa50309-
Norton Cancer InstituteLouisvilleKentucky40207-
Comprehensive Cancer Centers of Nevada - HendersonLas VegasNevada89169-
Kaiser Permanente Interstate Medical Office CentralPortlandOregon97227-
Hollings Cancer CenterCharlestonSouth Carolina29425-
Virginia Cancer SpecialistsGainesvilleVirginia20155-
Medical College of Wisconsin Cancer Center Clinical Trials OfficeMilwaukeeWisconsin53226-

Find similar trials in La Jolla, CA

By research site
University of California San Diego Moores Cancer Center· La Jolla, CARedlands Community Hospital· Redlands, CAThe Oncology Institute of Hope and Innovation· Whittier, CABaptist MD Anderson Cancer Center· Jacksonville, FLUnityPoint Health - Iowa Oncology Research Association (IORA)· Des Moines, IANorton Cancer Institute· Louisville, KY

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