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

PHASE2RecruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

October 1, 2025

Study Completion Date

October 1, 2027

Conditions
Monoclonal Gammopathy of Uncertain Significance
Interventions
DRUG

Zanubrutinib Oral Product

Treatment will consist of Rituximab administered at 375 mg/m2 intravenously on Cycle 1 Days 1, 8, 15, 22 only (4 total infusions). The experimental part of the treatment will consist of Zanubrutinib, given once daily 320 mg (4 x 80 mg capsules). Although Zanubrutinib is taken continuously, therapy cycles are calculated per 28 days. Participants will be treated for a minimum of 6 cycles per protocol. Participants who still use Zanubrutinib at the end of study can continue indefinitely until registration and reimbursement in the Netherlands.

Trial Locations (1)

3584CX

RECRUITING

University Medical Center Utrecht, Utrecht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BeiGene

INDUSTRY

lead

UMC Utrecht

OTHER