EUCTR2015-002855-85-NL进行中（未招募）1 期
A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in UNFIT (i.e. HCT-CI = 3) AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients aged >=66 years.A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT-older AML/high-risk MDS patients. - HOVON 135 AML /SAKK 30/15
HOVON Foundation0 个研究点目标入组 170 人开始时间: 2015年11月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with:
- •-a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or
- •-acute leukemia's of ambiguous lineage according to WHO 2008 or
- •-a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R > 4.5
- •Patients 66 years and older.
- •Patients NOT eligible for standard chemotherapy, defined as HCT-CI = 3. or
- •Patient NOT eligible for standard chemotherapy for other reasons (wish of patient).
- •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 = 2.5 mg/dL (= 221.7 µmol/L), 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).
- •Male patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
- •Written informed consent.
- •Patient is capable of giving informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •Acute promyelocytic leukemia.
- •Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period ( = 5 days) with Hydroxyurea is allowed
- •Diagnosis of any previous or concomitant malignancy is an exclusion criterion: 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.
- •Blast crisis of chronic myeloid leukemia.
- •Inability to discontinue anti-coagulants
- •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 or
- •- Unstable cardiac arrhythmias
- •Patient has had major surgery within the past 4 weeks or a major wound that has not fully healed.
- •Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization.
- •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.
- •Patient has symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement)
- •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 consent.
- •Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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