NL-OMON19923招募中不适用
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.<br>A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT-older AML/high-risk MDS patients.
HOVON Data Center0 个研究点目标入组 185 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 185
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
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
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 any anti-coagulants (including ascal)
- •♦ 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
- •♦ 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
研究者
相似试验
已完成
不适用
A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome.Myelodysplastic syndrome (MDS)NL-OMON20915Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Postbus 2040; 3000 CA Rotterdam; Tel: +31 10 704 1560 Fax: +31 10 704 1028; e-mail: hdc@erasmusmc.nl200
已完成
2 期
Lapatinib in Combination With VinorelbineCancerNCT01013740Novartis Pharmaceuticals112
招募中
不适用
A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years.NL-OMON25046HOVON foundation200
招募中
不适用
A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged >66 years .Acute Myeloid Leukemia (AML), MDSNL-OMON25024HOVON Data Center230
已完成
不适用
A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years.Acute Myeloid leukemia (AML), RAEBNL-OMON22002HOVON Data Center200