EICHORCondition: Anti-MAG IgM-associated Demyelinating Polyneuropathy · Sponsor: Azienda Ospedaliera di Padova
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The MAZINGA study is a multicenter, open-label, single-arm Phase IIA clinical trial designed to evaluate the efficacy, safety, and tolerability of zanubrutinib in patients with IgM anti-myelin-associated glycoprotein (anti-MAG) antibody-associated demyelinating polyneuropathy. Anti-MAG neuropathy is a rare immune-mediated disorder frequently associated with IgM monoclonal gammopathies, including monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, and other indolent B-cell lymphoproliferative disorders. The primary objective of the study is to determine whether 12 months of treatment with zanubrutinib leads to a clinically meaningful neurological improvement, defined as an improvement of at least one point in at least two validated neurological scales. These include reductions in the Overall Neuropathy Limitations Scale (ONLS), INCAT Disability Score, and INCAT Sensory Sum Score (ISS), along with increases in the Medical Research Council (MRC) sum score and the I-RODS functional score. Secondary objectives include the evaluation of neurophysiological improvement assessed by nerve conduction studies (ENG/EMG), particularly changes in distal motor latency, terminal latency index, and sensory action potential amplitude at 12, 24, and 48 months. Additional secondary endpoints assess hematological efficacy through overall response rate (complete response, very good partial response, or par…
This description comes directly from the study's public registry record.
Andrea Visentin, Dr, Medical Doctor · +39 049 821 2298 · ANDREA.VISENTIN@UNIPD.IT
Manuela Taurisano, Pharmacy, PhD · +39 3513590476 · mtaurisano@clinopshub.com
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Inclusion Criteria (MAIN): * age ≥18 years; * diagnosis of anti-MAG antibody polyneuropathy; * neurophysiological (ENG/EMG) evidence of a demyelinating polyneuropathy with evidence of disproportionately prolonged distal motor latency in one or more nerves -excluding the median nerve if related to carpal tunnel syndrome * IgM monoclonal protein underlying MGUS (based on the WHO definition of clonal lympho- plasmocytes \<10%), Waldenstrom macroglobulinemia (based on the WHO definition of clonal lympho-plasmocytes ≥10%), marginal zone lymphoma, chronic lymphocytic leukemia or low- grade lymphoma not otherwise specified; * presence of anti MAG antibodies (titer ≥ 7.000 BTU); * neurophysiological (ENG/EMG) evidence of demyelinating polyneuropathy. Exclusion Criteria (MAIN): * Previous treatment with BTK inhibitors * Aggressive non-Hodgkin lymphoma or IgM multiple myeloma * Evidence of moderate or severe motor nerve axonal damage, defined when occurring diffuse polyneuropathic denervation or a recruitment pattern lower than intermediate in ≥50% of muscles examined, and/or INCAT at lower limbs ≥4. * ECOG \>3 * Use of strong CYP3A inducers within 14 days prior to the first dose of zanubrutinib
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| CTU Ematologia, Grande Ospedale Metropolitano Niguarda | Milan, Milan, Italy | Recruiting |
| UOC Ematologia, Azienda Ospedale Università Padova | Padova, PD, Italy | Recruiting |
| SC UCO Ematologia, Ospedale Maggiore di Trieste | Trieste, Trieste, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07392229