Peripheral anti-MAG neuropathy, waldenstrom macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, monoclonal gammopathy of unknown significance
Conditions
Brief summary
The proportion of patients with neurological improvement defined as improvement of at least 1 point in at least 2 neurological scales (ONLS, INCAT disability, INCAT sensory sum scores (ISS), MRC sum score, I-RODS functional score) at 12 months of zanubrutinib treatment.
Detailed description
● The proportion of patients with neurological improvement after 24 and 48 months of zanubrutinib; ● the proportion of patients with ENG/EMG improvement since the baseline, assessing decrease of distal motor latency, increase of terminal latency index, increase of sensory nerve action potential amplitude (see criteria of evaluation) at upper limbs after zanubrutinib treatment at 12, 24 and 48 months; ● levels of monoclonal protein, IgM and of anti-MAG antibody titers at 12, 24 and 48 months.
Interventions
DRUGZanubrutinib
Sponsors
Azienda Ospedaliera di Padova
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with neurological improvement defined as improvement of at least 1 point in at least 2 neurological scales (ONLS, INCAT disability, INCAT sensory sum scores (ISS), MRC sum score, I-RODS functional score) at 12 months of zanubrutinib treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| ● The proportion of patients with neurological improvement after 24 and 48 months of zanubrutinib; ● the proportion of patients with ENG/EMG improvement since the baseline, assessing decrease of distal motor latency, increase of terminal latency index, increase of sensory nerve action potential amplitude (see criteria of evaluation) at upper limbs after zanubrutinib treatment at 12, 24 and 48 months; ● levels of monoclonal protein, IgM and of anti-MAG antibody titers at 12, 24 and 48 months. | — |
Countries
Italy
Outcome results
None listed