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RecruitingPhase 2NCT05249959

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

Consolidation With ADCT-402 (Loncastuximab Tesirine) After a Short Course of Immunochemotherapy: a Phase II Study in BTKi-treated (or BTKi Intolerant) Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Patients

Sponsor

Fondazione Italiana Linfomi - ETS

Enrollment

49 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

Conditions

Refractory Mantle Cell LymphomaRelapsed Mantle Cell Lymphoma

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).

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called loncastuximab tesirine as a consolidation treatment for patients with mantle cell lymphoma (a type of blood cancer) that has come back or stopped responding to treatment. After a short course of combination chemotherapy, patients receive this drug to try to keep the cancer from returning. **You may be eligible if...** - You are between 18 and 84 years old - You have been diagnosed with mantle cell lymphoma that has relapsed or is not responding to treatment (after 1 to 4 prior lines of therapy) - You have previously been treated with a BTK inhibitor (a type of targeted therapy) - You have not recently had bendamustine, or at least one year has passed since your last dose - You have measurable disease that can be tracked on imaging **You may NOT be eligible if...** - You have serious liver, heart, or blood problems - You have active, uncontrolled infections - You have certain other active cancers - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGConsolidation 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

DRUGConsolidation 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

Locations(21)

ASST Spedali Civili di Brescia

Brescia, Italy, Italy

S.C. Ematologia - A.S.O. "SS Antonio e Biagio e Cesare Arrigo"

Alessandria, Italy

S.C. di Ematologia - A.O. S. Croce e Carle

Cuneo, Italy

Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Ematologia - Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia

Genova, Italy

Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Italy

S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

UOC Ematologia Oncologica - Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale

Naples, Italy

SCDU Ematologia - AOU Maggiore della Carità di Novara

Novara, Italy

Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello

Palermo, Italy

Divisione di Ematologia - IRCCS Policlinico S. Matteo di Pavia

Pavia, Italy

Ematologia - Ospedale delle Croci

Ravenna, Italy

Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

U.O. di Ematologia - Ospedale degli Infermi di Rimini

Rimini, Italy

Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia

Roma, Italy

U.O. Ematologia - Istituto Clinico Humanitas

Rozzano, Italy

S.C. Ematologia Universitaria - A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy

S.C di Ematologia - Ospedale Ca Foncello

Treviso, Italy

U.O.C Ematologia e Trapianto - A.O. C. Panico

Tricase, Italy

SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)

Trieste, Italy

U.O. Ematologia - AOU Integrata di Verona

Verona, Italy

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NCT05249959

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