πŸ›οΈ Verified NIH Record β€’ Updated 2025-12-01

ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy (NCT05065554)

Phase II Study on Acalabrutinib and Anti-CD20 Antibody in Patients With Predominantly Demyelinating Neuropathy With or Without Anti-MAG

πŸ”΅ Active, Not Recruiting Phase2 πŸ’Š Investigational Drug / Biologic Sponsor: Shayna Sarosiek, MD

🩺 Plain-English Summary (8th-Grade Level)

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 WaldenstrΓΆm macroglobulinemia WM related neuropathies. The names of the study drugs involved in this study are/is: * Acalabrutinib * Rituximab or similar CD20 antibody

Who can join: Review the eligibility criteria below.

Location: Massachusetts General Hospital β€” Boston, Massachusetts

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (2 Sites)

  • Massachusetts General Hospital β€” Boston, Massachusetts
  • Dana Farber Cancer Institute β€” Boston, Massachusetts

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All IgM MGUS clinical trials

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—