drugset / Trial / NCT03891355

Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL

NCT03891355

Phase 2 Unknown 16 enrolled Fondazione Italiana Linfomi - ETS
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, multicenter, single arm, phase II trial designed to evaluate activity and the safety of the combination of Carfilzomib (K), Lenalidomide (R) and Dexamethasone (D) in patients with mantle cell lymphoma (MCL) relapsed/refractory (R/R) or intolerant to BTK inhibitor (BTKi) monotherapy or BTKi containing regimens with active disease necessitating treatment.

Timeline

Start
2019-09-30
Primary completion
2020-12-04
Completion
2022-12-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Carfilzomib Other / unclassified 27 mg/m2 Intravenous
Subject Dexamethasone Small molecule 10 mg Oral
Subject Dexamethasone Small molecule 20 mg Oral
Subject Lenalidomide Other / unclassified 10 mg
Subject Lenalidomide Other / unclassified 25 mg

Indications