Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.
Recruiting
Phase 2
Interventional Study
Relapsed Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 79
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 49 (estimated)
- Sponsor
- Fondazione Italiana Linfomi - ETS · Other
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About This Trial
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 Ita…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification
* Age ≥ 18 and \< 85 years
* Relapsed/Refractory disease after one, two, three or four lines of treatment
* Bendamustine-naive or relapsed after at l…
Contacts