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 (Jun 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
Treatments studied
Targeted therapy
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
Demographics
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.
Frequently asked questions
Is NCT05249959 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bendamustine-containing regimen, bendamustine-containing regimen, CD19 targeting agents disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 79 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages