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NCT05065554 · ClinicalTrials.gov registry record · Phase 2
ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy
A Phase 2 study of Waldenstrom Macroglobulinemia and Neuropathy;Peripheral, sponsored by Shayna Sarosiek, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT05065554 is a Phase 2 study of Waldenstrom Macroglobulinemia and Neuropathy;Peripheral that is active but no longer recruiting, run by Shayna Sarosiek, MD. The registered enrollment target is 12 participants, below the 473-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05065554, a Phase 2 study of Waldenstrom Macroglobulinemia and Neuropathy;Peripheral, is active but no longer recruiting, sponsored by Shayna Sarosiek, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- DRUG Rituximab
- DRUG Acalabrutinib
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05065554
The ClinicalTrials.gov registry entry for NCT05065554 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (97% lower). The listed sponsor is Shayna Sarosiek, MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Waldenstrom Macroglobulinemia appearing as the primary indexed condition, and to 2 interventions - of which Rituximab is the first listed.
NCT05065554 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05065554 about?
NCT05065554 is a clinical study titled "ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy". 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 Wa...
What is the current status of trial NCT05065554?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2021-11-16. Estimated completion is 2028-10-01.
What conditions does trial NCT05065554 study?
This clinical trial studies the following conditions: Waldenstrom Macroglobulinemia, Neuropathy;Peripheral, IgM MGUS.
What interventions are being tested in trial NCT05065554?
The interventions under investigation include: Rituximab (DRUG), Acalabrutinib (DRUG).
Who is sponsoring clinical trial NCT05065554?
This trial is sponsored by Shayna Sarosiek, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05065554 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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