drugset / Trial / NCT05065554

ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy

NCT05065554

Phase 2 Active not recruiting 12 enrolled Shayna Sarosiek, MD AstraZeneca · collab
NaSingle-groupOpen-labelTreatment

Summary

In this research study, is combining a new treatment acalabrutinib with a standard treatment, rituximab or other CD20 antibody, to determine whether this combination is safe and effective for participants with Immunoglobulin (Ig) M monoclonal gammopathy of undetermined significance ( IgM MGUS) or Waldenström macroglobulinemia WM related neuropathies. The names of the study drugs involved in this study are/is: * Acalabrutinib * Rituximab or similar CD20 antibody

Timeline

Start
2021-11-16
Primary completion
2026-12-01
Completion
2028-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule Oral
Subject Rituximab Monoclonal antibody Intravenous