drugset / Trial / NCT05249959
Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2022-03-21
- Primary completion
- 2026-03-21
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Loncastuximab Tesirine | Other / unclassified | 75 ug/kg | — |
| Background | Bendamustine | Small molecule | 70 mg/m2 | — |
| Background | Bendamustine | Small molecule | 100 mg | — |
| Background | Cytarabine | Small molecule | 500 mg/m2 | — |
| Background | Cytarabine | Small molecule | 500 mg | — |
| Background | Cytarabine | Small molecule | — | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |