Actively Recruiting
Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.
Led by Fondazione Italiana Linfomi - ETS · Updated on 2026-01-05
49
Participants Needed
21
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically documented diagnosis of Mantle Cell Lymphoma as defined by the 2017 WHO classification
- Age 18 years or older and younger than 85 years
- Relapsed or refractory disease after one to four lines of treatment
- Bendamustine-naive or relapse at least one year after last bendamustine treatment
- Previous treatment with BTKi monotherapy or BTKi-containing regimens, or intolerance to BTKi, with active disease requiring treatment
- Previous anti-CD19 treatment allowed if CD19 expression confirmed
- Venetoclax-treated patients allowed
- Eligible for stem cell transplant
- Measurable nodal or extranodal disease of at least 1.5 cm in longest diameter, or bone marrow involvement only
- ECOG performance status 2 or less (unless due to MCL)
- Adequate laboratory values unless due to bone marrow involvement: ANC > 1.0x10^9/L, platelets ≥ 75,000/mm3, creatinine clearance ≥ 40 mL/min, AST and ALT ≤ 3.0 times upper limit of normal, bilirubin ≤ 1.5 times upper limit of normal (unless due to Gilbert's syndrome or non-hepatic origin)
- Able to understand and sign informed consent
- Able to adhere to study visit schedule and requirements
- Life expectancy of at least 3 months
- Women of childbearing potential and men agree to use effective contraception during the study and for specified periods after last dose of loncastuximab tesirine
You will not qualify if you...
- Relapse less than one year after bendamustine-containing regimen
- Known allergy to human antibodies
- Allogeneic stem cell transplant within 6 months prior to study drug
- Allogeneic stem cell transplant with active or uncontrolled graft-versus-host disease
- Previous treatment with CD19 targeting agents
- More than four previous lines of treatment (excluding autologous transplant as consolidation)
- Active second cancer in the last three years except certain skin, prostate, cervical, or breast cancers
- Major surgery or anticancer therapy within 14 days prior to study drug start without sponsor approval
- Cardiovascular disease NYHA class 2 or higher
- Significant neurologic, psychiatric, endocrine, metabolic, immune, or liver disease affecting participation or consent
- Uncontrolled infections including viral, bacterial, or fungal
- Chronic or acute hepatitis B or C requiring treatment (some inactive carriers allowed)
- HIV positive
- Active central nervous system lymphoma involvement
- Congenital long QT syndrome or corrected QT interval over 480 msec unless pacemaker or bundle branch block
- Any other serious medical condition judged by investigator to risk patient safety or participation
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 21 locations
1
ASST Spedali Civili di Brescia
Brescia, Italy, Italy, 25123
Actively Recruiting
2
S.C. Ematologia - A.S.O. "SS Antonio e Biagio e Cesare Arrigo"
Alessandria, Italy
Actively Recruiting
3
S.C. di Ematologia - A.O. S. Croce e Carle
Cuneo, Italy, 12100
Actively Recruiting
4
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50141
Actively Recruiting
5
Ematologia - Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia
Genova, Italy, 16132
Actively Recruiting
6
Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy, 20133
Actively Recruiting
7
S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
8
UOC Ematologia Oncologica - Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
9
SCDU Ematologia - AOU Maggiore della Carità di Novara
Novara, Italy, 28100
Actively Recruiting
10
Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy, 90146
Actively Recruiting
11
Divisione di Ematologia - IRCCS Policlinico S. Matteo di Pavia
Pavia, Italy, 27100
Actively Recruiting
12
Ematologia - Ospedale delle Croci
Ravenna, Italy, 48121
Actively Recruiting
13
Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, Italy, 42123
Actively Recruiting
14
U.O. di Ematologia - Ospedale degli Infermi di Rimini
Rimini, Italy, 47923
Actively Recruiting
15
Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia
Roma, Italy, 00161
Actively Recruiting
16
U.O. Ematologia - Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
17
S.C. Ematologia Universitaria - A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy, 10126
Actively Recruiting
18
S.C di Ematologia - Ospedale Ca Foncello
Treviso, Italy, 31100
Actively Recruiting
19
U.O.C Ematologia e Trapianto - A.O. C. Panico
Tricase, Italy, 73039
Actively Recruiting
20
SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
Trieste, Italy, 34121
Actively Recruiting
21
U.O. Ematologia - AOU Integrata di Verona
Verona, Italy, 37134
Actively Recruiting
Research Team
S
Stefania Badiali
CONTACT
G
Giorgio Priolo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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