A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.
A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.
批准号:
10706187
负责人:
RICHARD CHILDS
金额:
$82.92万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
AdultAllogenicAnemiaCOVID-19Clinical TrialsConsentDecision MakingDiseaseEnrollmentExclusion CriteriaHomologous TransplantationHumanImmuneImpaired cognitionIndividualInstitutional Review BoardsLegalMediatingMentally Disabled PersonsPatientsPersonal SatisfactionProcessProtocols documentationRegulationResearch PersonnelResearch SubjectsSafetyTestingThrombocytopeniaTransplantationUncertaintyVulnerable Populationsarmclinical efficacyclinically relevantcytopeniahuman subjectinclusion criteriamemberphase 2 studypost-transplant
中文摘要
本研究的主要目的是评估移植后免疫介导性细胞减少患者同种异体骨髓移植后福斯塔马替尼的安全性和早期临床疗效。该试验是主要试验的延伸,保留了那些在主要试验中对福司他替尼治疗有反应的患者。
英文摘要
The primary objective of this study is to evaluate the safety and early clinical efficacy of fostamatinib following allogeneic BM transplantation in patients with post transplant immune mediated cytopenias. This trial is the extension arm of the primary trial, with enrollment reserved for those responding to fostamatinib treatment on the primary trial.
Secondary objectives will be to assess clinically relevant endpoints of safety.
Subject Inclusion and Exclusion Criteria will be reviewed as appropriate by a member of the study team. If there is any uncertainty, the PI should make the decision on whether a potential subject is eligible for study enrollment.
Certain human subjects are categorized as vulnerable populations and require special treatment with respect to safeguards of their well-being. For this clinical trial, examples include cognitively impaired or mentally disabled persons and intubated individuals who are sedated. When it is determined that a potential research subject is cognitively impaired, federal and institutional regulations permit researchers to obtain consent from a legally authorized representative (LAR). The study team will obtain consent from these vulnerable subjects using an IRB-approved protocol- specific process for consent using a LAR.
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批准号:8344766
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项目类别:
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资助金额:$269.38万
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财政年份:--
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负责人:RICHARD CHILDS
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依托单位:
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批准号:10017619
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资助金额:$377.58万
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批准号:10253913
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资助金额:$75.96万
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资助金额:$0.0万
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负责人:RICHARD CHILDS
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批准号:10934198
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项目类别:
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资助金额:$42.09万
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资助金额:$260.95万
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负责人:RICHARD CHILDS
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资助金额:$296.18万
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财政年份:--
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负责人:RICHARD CHILDS
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财政年份:--
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负责人:RICHARD CHILDS
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依托单位:
Allogeneic Immunotherapy for cancer and nonmalignant hematological disorders
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资助金额:$307.53万
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依托单位:
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批准号:8149488
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项目类别:
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资助金额:$291.51万
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资助金额:$157.1万
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项目类别:
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资助金额:$39.27万
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财政年份:--
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依托单位:
Cyclosporine Inhalation Solution (CIS) treatment of Bronchiolitis Obliterans
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资助金额:$46.05万
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财政年份:--
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负责人:RICHARD CHILDS
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依托单位:
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批准号:6966961
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项目类别:
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资助金额:$0.0万
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财政年份:--
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负责人:RICHARD CHILDS
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依托单位:
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批准号:6818008
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项目类别:
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资助金额:$0.0万
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财政年份:--
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负责人:RICHARD CHILDS
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依托单位:
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批准号:10706163
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项目类别:
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资助金额:$326.42万
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财政年份:--
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负责人:RICHARD CHILDS
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依托单位:
海外基金