Clinical Trial

Zanubrutinib Treatment in Patients With IgM Monoclonal Gammopathy and Antri-MAG Related Polyneuropathy

Study acronym: MAGNAZ
Active, Not Recruiting Phase 2
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Summary
The objective of this investigator-initiated phase II single-arm open-label clinical trial is to investigate neurological response rate, safety and tolerability of Zanubrutinib 320 mg daily in combination with Rituximab 375 mg/m2 (standard therapy) for the treatment of immunoglobulin M monoclonal gammopathy of unknown significance (IgM MGUS) related polyneuropathy with Myelin Associated Glycoprotein antibodies (anti-MAG). 42 adult patients will be included in two Dutch hospitals (University Medical Center Utrecht and Amsterdam University Medical Center). This trial consists of a 6-month treatment period, after which the hematological response will be evaluated. Adequately responding participants (at least partial response) will be treated for an additional 6 months, after which hematological response will be re-evaluated. Participants with at least a very good partial response will remain on treatment. Non-responding participants will be followed for clinical outcomes only. The total study period per participant will be 36 months.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-07-06; most recent amendment 2026-05-04.
Status change: Recruiting → Active, Not Recruiting 2026-05-04
Status change: Not Yet Recruiting → Recruiting 2024-07-12
Trial Details
NCT Number NCT05939037
Lead Sponsor UMC Utrecht
Collaborators: BeiGene
Conditions Monoclonal Gammopathy of Uncertain Significance
Enrollment 35 participants
Start Date 2024-03-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-08