Active — Not RecruitingPhase 3

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

United States440 participantsStarted 2020-09-16

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count ≥1000/μL (off growth factors for at least 72 hours)
✓. Platelet count ≥100000/μL without transfusion within the past 2 weeks
✓. ALT, AST, and GGT ≤2.5 × the upper limit of normal (ULN)
✓. Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)
✓. Calculated creatinine clearance ≥30 mL/min by the Cockcroft and Gault equation

Exclusion criteria

✕. CD4+ T-cell (CD4+) counts \<350 cells/μL
✕. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening
✕. Not on anti-retroviral therapy, or on anti-retroviral therapy for \<4 weeks at the time of screening
✕. HIV viral load ≥400 copies/mL

What they're measuring

Progression-free Survival (PFS)

Timeframe: Up to 4 years

Trial details

NCT IDNCT04384484

SponsorADC Therapeutics S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Relapsed Diffuse Large B-Cell Lymphoma trials