NL-OMON52317撤回2 期
Multicenter, open*label, phase II study in patients with monoclonal gammopathy of unknown significance (MGUS) and anti Myelin Associated Gycoproteine (MAG) Neuropathy and Zanubrutinib Treatment * MAGNAZ trial - Magnaz
niversitair Medisch Centrum Utrecht0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Able to provide written informed consent and understand and comply with the
- •requirements of
- •- Demyelinating polyneuropathy defined by electrophysiological criteria
- •according to EFNS/PNS
- •PDN guideline, 201019
- •- Some functional impairment; defined as an iRODS * 44 at baseline
- •- Age * 18 years
- •- IgM MGUS, defined as the presence of an IgM M protein (detectable but < 30
- •g/L) AND elevated total IgM level in serum
- •- Presence of anti MAG antibodies * 10.000 titer units, measured with the
- •Bühlmann ELISA
- •- ECOG performance score 0, 1, or 2
- •- Adequate hematological laboratory values defined as
- •hemoglobin * 5.0 mmol/L neutrophils > 1.0 × 10^9/L and platelets > 100 × 10^9/L
- •- Adequate hepatic and renal function laboratory values defined as ASAT/ALAT
- •< 3 × ULN, bilirubin < 2.0 × ULN and creatinine clearance * 30 ml/min
- •- No history of severe bleeding disorder such as hemophilia A, hemophilia B,
- •von Willebrand
- •disease, or history of spontaneous bleeding requiring blood transfusion or
- •other medical intervention
- •- Previous treatment with intravenous immunoglobulins is allowed if > 3
- •months before inclusion
- •- Previous treatment for PNP with Anti CD20 MoAb and/or cyclophosphamide is
- •allowed only if
- •given > 6 months before inclusion
排除标准
- •- Hematological malignancy e.g known Multiple Myeloma or confirmed Waldenstrom*s
- •Macroglobulinemia based on bone marrow analysis
- •- Any history of malignancy of any organ system (other than localized basal or
- •squamous cell
- •carcinoma of the skin, superficial bladder cancer or carcinoma in situ of the
- •cervix or breast),
- •treated or untreated within the last 3 years
- •- History of ischemic stroke within 180 days before first dose of Zanubrutinib.
- •- History of CNS hemorrhage.
- •- History of inherited or acquired hemorrhagic disorder
- •- Prior treatment with purine analogues (fludarabine or cladribine)
- •- Prior treatment with a BTK inhibitor
- •- Major surgery within 4 weeks of study treatment
- •- Participation in another interventional clinical trial
- •- Women with child*bearing potential (WOCBP) not able or willing to prevent
- •pregnancy and
- •lactating women as well. WOCBP will agree to use highly effective contraception
- •for the duration of the trial treatment and for 120 days after treatment stop
- •- Other known concomitant causes of chronic (demyelinating) PNP, including
- •Charcot Marie Tooth Disease, other hereditary neuropathies, diabetes mellitus,
- •use of amiodarone, past or current dependence on alcohol, other lymphoma or
- •malignant blood dyscrasias, previous Guillain*Barré syndrome
- •- Currently active, clinically significant cardiovascular disease such as
- •uncontrolled arrhythmia,
- •congestive heart failure, any Class 3 or 4 cardiac disease (congestive heart
- •failure) as defined by
- •the New York Heart Association (NYHA) Functional Classification, or history of
- •infarction within 6 months of screening
- •- A history of clinically significant ECG abnormalities, or any of the
- •following ECG abnormalities
- •at screening:
- •o QTcF >450 msec (males)
- •o QTcF >460 msec (females)
- •o History of familial long QT syndrome or known family history of Torsades de
- •o Use of agents known to prolong the QT interval unless they can be permanently
- •discontinued for the duration of the study
- •o second degree atrioventricular (AV) block Type II, or third*degree AV block
- •* Controlled atrial fibrillation is allowed
- •- Unable to swallow capsules or disease significantly affecting
- •gastrointestinal function such as
- •malabsorption syndrome, resection of the stomach or small bowel, symptomatic
- •inflammatory
- •bowel disease, or partial or complete bowel obstruction
- •- Uncontrolled active systemic infection or recent infection requiring
- •parenteral anti*microbial
- •therapy that was completed * 14 days before the first dose of study drug.
- •Active tuberculosis
- •- Known infection with human immunodeficiency virus (HIV), or serologic status
- •reflecting active
- •hepatitis B or hepatitis C infection as follows: Presence of hepatitis B
- 另有 12 项未显示
研究者
相似试验
招募中
1 期
Multicenter, open-label, phase II study in patients with immunoglobulin M monoclonal gammopathy of unknown significance and Myelin Associated Glycoprotein antibodies related polyneuropathy and Zanubrutinib TreatmentIgM monoclonal gammopathy of unknown significance (MGUS) and myelin associated glycoprotein (MAG) antibodies associated polyneuropathyMedDRA version: 21.1Level: LLTClassification code: 10066137Term: Anti-MAG neuropathy Class: 10029205CTIS2023-505933-29-00niversity Medical Center Utrecht42
招募中
2 期
A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients
GMMG-CONCEPTMultiple Myeloma2024-511791-32-00University Medical Center Hamburg-Eppendorf246
进行中（未招募）
1 期
A Study of CGT9486 in Patients with Advanced Systemic MastocytosisAdvanced Systemic Mastocytosis (AdvSM)MedDRA version: 27.0Level: LLTClassification code 10056453Term: Aggressive systemic mastocytosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-001010-10-FRCogent Biosciences, Inc.140
进行中（未招募）
1 期
A Study of CGT9486 in Patients with Advanced Systemic MastocytosisAdvanced Systemic Mastocytosis (AdvSM)MedDRA version: 20.0Level: LLTClassification code 10056453Term: Aggressive systemic mastocytosisSystem Organ Class: 100000004864EUCTR2021-001010-10-PLCogent Biosciences, Inc.120
进行中（未招募）
1 期
A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic MastocytosisAdvanced Systemic Mastocytosis (AdvSM)MedDRA version: 20.0Level: LLTClassification code 10056453Term: Aggressive systemic mastocytosisSystem Organ Class: 100000004864EUCTR2021-001010-10-ESCogent Biosciences, Inc.140