Clinical Trial

ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy

Active, Not Recruiting Phase 2
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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
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-09-29; most recent amendment 2025-12-01.
Status change: Recruiting → Active, Not Recruiting 2025-12-01
Status change: Not Yet Recruiting → Recruiting 2021-11-22
Trial Details
NCT Number NCT05065554
Lead Sponsor Shayna Sarosiek, MD
Collaborators: AstraZeneca
Conditions IgM MGUS, Waldenstrom Macroglobulinemia, Neuropathy;Peripheral
Enrollment 12 participants
Start Date 2021-11-16
Primary Completion 2026-12-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-05