ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy
United States12 participantsStarted 2021-11-16
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must meet the following criteria on screening examination to be eligible to participate. Screening evaluations including consent, physical exam, and laboratory assessments will be done within 30 days prior to Cycle 1 Day 1. Bone marrow biopsy \&aspirate, skin (fat) biopsy, EMG, and CT C/A/P will be done within 90 days prior to Cycle1 Day 1.
* Presence of an IgM monoclonal paraprotein on serum immunofixation electrophoresis
* Diagnosis of IgM MGUS or WaldenstrÓ§m macroglobulinemia using the criteria from Owen RG, Treon SP, Al-Katib A, Fonseca R, Greipp PR, McMaster ML, et al.Clinicopathological definition of Waldenstrom's macroglobulinemia: consensus panel recommendations from the Second International Workshop on Waldenstrom's Macroglobulinemia. Semin Oncol. 2003. 30(2): 110-5.
* WM diagnostic criteria
* IgM monoclonal gammopathy of any concentration
* Bone marrow infiltration by small lymphocytes showing plasmacytoid/plasma cell differentiation
* Intertrabecular pattern of bone marrow infiltration
* Surface IgM+, CD5 +/-, CD10-, CD19+, CD20+, CD22+, CD23-, CD25+, CD27+, FMC7+, CD103-, CD138- immunophenotype\* --- Variations from this immunophenotypic profile can occur. However, care should be taken to satisfactorily exclude other lymphoproliferative disorders. This is most relevant in CD5+ cases, for which chronic lymphocytic leukemia and mantle cell lymphoma require specific exclusion before a diagnosis of WM can be made.
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