EUCTR2009-013094-17-NL进行中（未招募）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.A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML - HOVON 103 AML Lenalidomide
HOVON Foundation0 个研究点目标入组 240 人开始时间: 2009年8月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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 eligible for standard chemotherapy.
- •- Patients = 66 years.with a cytopathologically confirmed diagnosis according WHO classification of
- •o AML (not APL) (see appendix A) or
- •o refractory anemia with excess of blasts (RAEB) with an IPSS score = 1.5
- •- Patients of any age = 18 years with cytopathologically confirmed diagnosis according WHO classification of
- •o AML with very poor risk AML
- •- Subjects with secondary AML progressing from antecedent (at least 4 months
- •duration) myelodysplasia are also eligible.
- •- SGOT (AST) and SGPT (ALT) <= 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
- •- Total serum bilirubin level <= 1.5 x the ULN at the laboratory where the analysis was
- •- Serum creatinine concentration <= 1.5 x the ULN at the laboratory where the
- •analysis was performed.
- •- WHO performance status = 2
- •- Written informed consent.
- •- Female patients of childbearing potential must have a negative serum pregnancy
- •test within 2 weeks prior to enrollment.
- •- Male and female patients must use an effective contraceptive method during the
- •study and for a minimum of 6 months after study treatment.(see protocol appendix J for more information and specific requirements)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 230
排除标准
- •-Acute promyelocytic leukemia
- •- Patients previously treated for AML (any antileukemic therapy including
- •investigational agents), a short treatment period (< 2 weeks) with Hydroxyurea is
- •- Past or current history (within the last 2 years prior to randomization) of
- •malignancies except for the indication under this study and curatively treated:
- •- Basal and squamous cell carcinoma of the skin
- •- in situ carcinoma of the cervix
- •- Blast crisis of chronic myeloid leukemia
- •- Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular
- •accidents (= 6 months prior to randomization), myocardial infarction (= 6 months
- •prior to randomization), unstable angina, New York Heart Association (NYHA) grade
- •II or greater congestive heart failure,
- •- 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.
- •- Pregnant or lactating patients.
- •- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
研究者
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A study for the treatment of patients with leukemic cells in their bone marrow.patients = 66 years.with a confirmed diagnosis of o AML (not APL) (see appendix A) or o refractory anemia with excess of blasts (RAEB) with an IPSS score = 1.5 ORPatients of any age = 18 years with a confirmed diagnosis of o AML with very poor risk AMLMedDRA version: 14.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10037803Term: RAEBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-013094-17-NOHaukeland University Hospital, Helse Bergen240