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 ยท Updated on 2026-01-05
49
Participants Needed
21
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of loncastuximab tesirine as a consolidation therapy for patients with relapsed or refractory Mantle Cell Lymphoma (MCL) who have been treated with Bruton Tyrosine Kinase inhibitors (BTKi) or are intolerant to BTKi. This phase 2, multicenter, open-label, single-arm study aims to assess the effectiveness and safety of adding loncastuximab tesirine after a short course of salvage immunochemotherapy in these patients. The trial is sponsored by Fondazione Italiana Linfomi - ETS (FIL ETS). Participants will receive an induction phase with two cycles of Rituximab-Bendamustine-Cytarabine (R-BAC) every 28 days, followed by restaging. Patients who achieve complete response, partial response, or stable disease will then undergo consolidation with four infusions of loncastuximab tesirine over 12 weeks, with two infusions at a higher dose followed by two at a reduced dose. Those considered frail or unfit may receive a reduced induction regimen. The study includes a screening period of up to 21 days, treatment lasting up to 22 weeks, and a follow-up phase with visits every 4-8 weeks in the first year, then every 8-12 weeks for at least two more years. During the trial, patients will undergo disease evaluation at baseline, after induction, after consolidation, and every six months during follow-up, using CT, PET scans, and bone marrow biopsies as needed. Researchers will monitor treatment responses, minimal residual disease, and safety outcomes, with data collected for up to 36 months after treatment start. An extended follow-up period of two additional years will track long-term patient status and potential late effects. Patients who do not respond or whose disease progresses will receive standard clinical care.
CONDITIONS
Brief 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 confirmed diagnosis of Mantle Cell Lymphoma according to WHO 2017 classification
- Age 18 years or older and younger than 85 years
- Relapsed or refractory disease after one to four prior treatments
- Bendamustine-naive or relapsed at least one year after last bendamustine-containing treatment
- Previous treatment with BTKi monotherapy or BTKi-containing regimens, or intolerant to BTKi and requiring treatment
- Prior anti-CD19 treatment allowed if CD19 expression is confirmed
- Venetoclax-treated patients allowed
- Eligible for stem cell transplant
- Measurable nodal or extranodal disease of at least 1.5 cm in two dimensions or bone marrow involvement only
- ECOG performance status 0 to 2 unless due to MCL
- Laboratory values within specified limits unless caused by bone marrow involvement
- Ability to understand and sign informed consent
- Ability to follow study visit schedule
- Life expectancy of at least 3 months
- Women of childbearing potential and men must agree to use effective contraception during and after treatment for specified periods
You will not qualify if you...
- Relapse less than one year after bendamustine-containing regimen
- Known hypersensitivity to human antibodies
- Allogenic stem cell transplant within 6 months or with active graft-versus-host disease
- Previous treatment with CD19 targeting agents
- More than four prior treatment lines
- Active second malignancy within 3 years except certain specified cancers
- Major surgery or anticancer therapy within 14 days before study drug
- Heart failure NYHA class 2 or higher
- Significant neurologic, psychiatric, endocrine, metabolic, immune, or liver disease affecting participation
- Uncontrolled systemic infections including active viral infections
- Chronic or acute hepatitis B or C requiring treatment (with some exceptions)
- HIV positive
- Active central nervous system lymphoma involvement
- Congenital long QT syndrome or prolonged QTc interval
- Any other medical condition that would make participation unsafe or inappropriate
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 22 weeks
Participants receive two cycles of immunochemotherapy (R-BAC) over 8 weeks followed by restaging. Those with complete response, partial response, or stable disease then receive consolidation with loncastuximab tesirine consisting of 4 doses given every 3 weeks over 12 weeks.
Multiple visits during 2 cycles of immunochemotherapy over 8 weeks plus 4 infusion visits every 3 weeks over 12 weeks for consolidation
Duration - At least 3 years
After treatment, participants are followed up with visits every 4 to 8 weeks for the first year, then every 8 to 12 weeks for at least 2 years to monitor health status and disease progression.
Visits every 4-8 weeks for the first year, then every 8-12 weeks for at least 2 years
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
Unitร 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 Caritร 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 Unitะฐ 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 - Universitร "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. Cittร 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
G
Giorgio Priolo
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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