MedTrace Logo

ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy

NCT05065554 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-05

No results posted yet for this study

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

Conditions

Interventions

DRUG

Acalabrutinib

Dose per protocol, oral twice daily per cycle

DRUG

Rituximab

Premedications (including acetaminophen, an antihistamine, and a steroid) will be given per institutional guideline Dosage determined per protocol and cycle timepoint, Route IV or SQ per protocol and cycle timepoint, schedule per protocol and cycle timepoint

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Shayna Sarosiek, MD

    lead OTHER

Principal Investigators

  • Shayna R. Sarosiek, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2026-12-01
Completion
2028-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05065554 on ClinicalTrials.gov