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

Study acronym: MAGNAZ
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Oct 1, 2025 to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Oct 1, 2027 to Mar 1, 2029
    • Site details revised
    v4
  2. Enrollment target: 42 to 35
    • Eligibility criteria expanded, about 30 words
    • Site details revised
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2023 to Mar 1, 2024
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05939037
Lead Sponsor UMC Utrecht
Collaborators: BeiGene
Conditions
(from sponsor)		 Monoclonal Gammopathy of Uncertain Significance
Related terms Monoclonal Gammopathy of Undetermined Significance
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov