Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05939037 | Zanubrutinib Treatment in Patients With IgM Monoclonal Gammopathy and Antri-MAG Related Polyneuropathy | PHASE2 | ACTIVE NOT_RECRUITING | 35 | — | — | Mar 1, 2024 | Mar 1, 2029 | May 8, 2026 | 1 | Netherlands |
To assess the improvement of the functional neurological outcome of participants after treatment with Zanubrutinib in combination with Rituximab by The Inflammatory Neuropathy Cause and Treatment (INCAT) disability score (Overall score is the sum of arm and leg disability, scaled 0 (no problems) to 5 (disabled). A proportion of patients with ≥2 points improvement on the INCAT disability score wil be used as primary endpoint
To assess the safety and tolerability of the combined treatment with Rituximab and Zanubrutinib
Dose adjustments made per patient.Registration of drug accountability (counting of remaining capsules after each treatment cycle). Drug accountability will be presented as percentage.
| Name | Type | Description |
|---|---|---|
| Zanubrutinib Oral Product | DRUG | 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. |
Inclusion Criteria: * Able to provide written informed consent and understand and comply with the requirements of the study * Demyelinating PNP defined by the European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of paraproteinemic demyelinating neuropathies...