ZANUBRUTINIB, A SECOND GENERATION BTK INHIBITOR, IN ANTI-MAG ANTIBODY NEUROPATHY: A PHASE II ITALIAN MULTICENTER CLINICAL TRIAL (MAZINGA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- 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.
研究概览
简要总结
To investigate whether 12 months zanubrutinib treatment lead to an improvement of at least 1 point in at least 2 neurological scales, such as Overall Neuropathy Limitations Scale (ONLS), INCAT disability, INCAT sensory sum scores (ISS), MRC sum score, I-RODS functional score.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •● Age ≥18 years; ● diagnosis of anti-MAG antibody polyneuropathy; ● diagnosis of anti-MAG antibody polyneuropathy; ● IgM monoclonal protein underlying MGUS, 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)
排除标准
- •● Previous treatment with BTK inhibitors ● Aggressive non-Hodgkin lymphoma or IgM multiple myeloma ● Evidence of moderate or severe motor nerve axonal damage ● ECOG >3 ● Requiring ongoing therapy with strong or moderate cytochrome P450 3A (CYP3A) inducer. Use of strong/moderate CYP3A inducers within 14 days prior to the first dose of zanubrutinib (see Drug-interaction section). ● creatinine clearance <30mL/min
结局指标
主要结局
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.
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.
次要结局
- ● 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.
研究者
Principal Investigator
Scientific
Azienda Ospedaliera di Padova