OncoMatch/Clinical Trials/NCT05249959
Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.
Is NCT05249959 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C)) and Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at reduced dose (R-BAC, Rituximab - Bendamustine, Ara-C) for relapsed mantle cell lymphoma.
Treatment: Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C)) · Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at reduced dose (R-BAC, Rituximab - Bendamustine, Ara-C) — This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R/R (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients. The sponsor of this clinical trial is Fondazione Italiana Linfomi - ETS (FIL ETS).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression
If previous anti-CD19 treatment has occurred, tissue CD19 expression must be assessed by histology or flow cytometry
Performance status
ECOG/WHO 0–2
Prior therapy
Must have received: Bruton tyrosine kinase inhibitor — monotherapy or BTKi containing regimens
Previous treatment with BTKi (Bruton Tyrosine Kinase inhibitors) monotherapy or BTKi containing regimens with R/R disease; and/or patients who discontinued BTKi monotherapy or BTKi containing regimens for adverse events and have active disease necessitating treatment.
Cannot have received: bendamustine-containing regimen
Exception: relapsed at least one year after the last cycle
Bendamustine-naive or relapsed after at least one year after the last cycle of a bendamustine-containing regimen
Cannot have received: bendamustine-containing regimen
Subjects who have received a bendamustine containing regimen and relapsed less than one year after the end of treatment.
Cannot have received: CD19 targeting agents
Previous treatment with CD19 targeting agents.
Lab requirements
Blood counts
Absolute Neutrophil count (ANC) > 1.0×10^9/L; Platelet count ≥ 75,000/mm3
Kidney function
Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
Liver function
AST and ALT ≤ 3.0 x ULN; Bilirubin ≤ 1.5 x ULN (unless due to Gilbert's syndrome or of non-hepatic origin)
The following laboratory values at screening (unless due to bone marrow involvement by lymphoma): Absolute Neutrophil count (ANC) > 1.0×10^9/L; Platelet count ≥ 75.000/mm3; Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula); AST and ALT ≤ 3.0 x ULN; Bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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