NL-OMON55438已完成2 期
A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) adult AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients. A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT- AML/high-risk MDS patients. - HOVON 155 AM
HOVO0 个研究点目标入组 88 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
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
- •Patients with:
- •- a diagnosis of AML and related precursor neoplasms according to WHO 2016
- •classification (excluding acute promyelocytic leukemia) including secondary AML
- •(after an antecedent hematological disease (e.g. MDS) and therapy-related AML,
- •- a diagnosis of myelodysplastic syndrome with excess of blasts (MDS) and
- •IPSS-R > 4.5
- •Patients 18 years and older.
- •Patients NOT eligible for standard chemotherapy, defined as HCT-CI >= 3.
- •(Appendix G)
- •Patients NOT eligible for standard chemotherapy for other reasons (wish of
- •WBC <= 30 x109/L (prior hydroxyurea allowed for a maximum of 5 days, stop 2
- •days before start decitabine treatment)
- •Adequate renal and hepatic functions unless clearly disease related as
- •indicated by the following laboratory values:
- •- Serum creatinine <= 221.7 µmol/L (<= 2.5 mg/dL ), unless considered AML-related
- •- Serum bilirubin <= 2.5 x upper limit of normal (ULN), unless considered
- •AML-related or due to Gilbert*s syndrome
- •- Alanine transaminase (ALT) <= 2.5 x ULN, unless considered AML-related
- •WHO performance status 0, 1 or 2 (see Appendix D).
- •Patient is willing and able to use adequate contraception during and until 5
- •months after the last protocol treatment.
- •Written informed consent.
- •Patient is capable of giving informed consent.
排除标准
- •Acute promyelocytic leukemia.
- •Acute leukemia's of ambiguous lineage according to WHO 2016
- •Patient has symptomatic central nervous system (CNS) leukemia (NO routinely
- •lumbar puncture required to investigate CNS involvement)
- •Blast crisis of chronic myeloid leukemia.
- •Diagnosis of any previous or concomitant malignancy is an exclusion
- •except when the patient completed successfully treatment (chemotherapy and/or
- •surgery and/or radiotherapy) with curative intent for this malignancy at least
- •6 months prior to randomization. OR
- •except for basal and squamous cell carcinoma of the skin or in situ carcinoma
- •of the cervix
- •Patients previously treated for AML (any antileukemic therapy including
- •investigational agents), a short treatment period ( <= 5 days) with Hydroxyurea
- •Current concomitant chemotherapy, radiation therapy, or immunotherapy; other
- •than hydroxyurea
- •Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled
- •diabetes, infection, hypertension, pulmonary disease etc.)
- •Cardiac dysfunction as defined by:
- •- Myocardial infarction within the last 3 months of study entry, or
- •- Reduced left ventricular function with an ejection fraction < 40% as measured
- •by MUGA scan or echocardiogram or
- •- Unstable angina or
- •- New York Heart Association (NYHA) grade IV congestive heart failure (see
- •Appendix I) or
- •- Unstable cardiac arrhythmias.
- •History of stroke or intracranial hemorrhage within 6 months prior to
- •randomization.
- •Patient has a history of human immunodeficiency virus (HIV) or active
- •infection with Hepatitis C or B.
- •Patients known to be pregnant
- •Patients with a history of non-compliance to medical regimens or who are
- •considered unreliable with respect to compliance.
- •Patients with any serious concomitant medical condition which could, in the
- •opinion of the investigator, compromise participation in the study.
- •Patients who have senile dementia, mental impairment or any other psychiatric
- •disorder that prohibits the patient from understanding and giving informed
- •Any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule
研究者
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