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Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.

NCT05249959 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-01-05

No results posted yet for this study

Summary

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).

Conditions

  • Relapsed Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma

Interventions

DRUG

Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C))

Standard Induction phase (cycle 1-2 of R-BAC every 28 days according to the following schedule): * Rituximab 375 mg/m2 i.v. Day 1 * Bendamustine 70 mg/m2, Days 2 and 3 * Cytarabine 500 mg/m2, Day 2-4 After restaging at the End of Induction (EOI) patients with CR (complete response), PR (partial response) or SD (stable disease) will receive: CONSOLIDATION PHASE: * 2 infusions of loncastuximab tesirine at a dose of 150 microgram/kg every three weeks followed by * 2 infusions of loncastuximab tesirine at a dose of 75 microgram/kg every three weeks

DRUG

Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at reduced dose (R-BAC, Rituximab - Bendamustine, Ara-C)

Reduced Induction phase (cycle 1-2 with two different schedules for patients deemed FRAIL or UNFIT for standard induction therapy,based on protocol dose and as per medical judgment are allowed). * Rituximab 375 mg/m2 i.v. Day 1 * Bendamustine 70 mg/m2, Days 2 and 3 * Cytarabine 500 mg/m2, Day 2 and 3 or * Rituximab 375 mg/m2 i.v. Day 1 * Bendamustine 100 mg, Days 2 and 3 * Cytarabine 500 mg, Day 2 and 3 After restaging at the End of Induction (EOI) patients with CR (complete response), PR (partial response) or SD (stable disease) will receive: CONSOLIDATION PHASE: * 2 infusions of loncastuximab tesirine at a dose of 150 microgram/kg every three weeks followed by * 2 infusions of loncastuximab tesirine at a dose of 75 microgram/kg every three weeks

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Marco Ladetto · S.C. Ematologia - A.S.O. "SS Antonio e Biagio e Cesare Arrigo" di Alessandria

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2026-03-21
Completion
2029-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05249959 on ClinicalTrials.gov