ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Shayna Sarosiek, MD
Study ID
NCT05065554
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • IgM MGUS
  • Neuropathy;Peripheral
  • Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Dose per protocol, oral twice daily per cycle
  • Rituximab — DRUG
    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

Study Details

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

Key Dates

Start date
Nov 16, 2021
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Oct 1, 2028

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ACALABRUTINIB + RITUXIMAB/BIOSIMILAR
    Acalabrutinib and rituximab (or biosimilar) with be contained in the treatment regimen. Acalabrutinib will be administered twice daily, with 28 consecutive days defined as a treatment cycle. Acalabrutinib will be administered for 48 cycles or until disease progression or unacceptable toxicity. Rituximab will be administered on Days 1, 8, 15, and 22 of Cycles 1 and 4. Participants will have study visits every cycle for cycles 1-6, then every 3 cycles, with the next visit at Cycle 9, then C12, C15, etc. Participants will continue acalabrutinib until disease progression or intolerable adverse effect develops. They will be followed for up to 2 years after completion of 48 cycles of treatment or until death

Primary Outcome Measure

Overall hematologic response rate [ Time Frame: baseline to 6 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-

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By research site
Dana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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