EUCTR2005-002830-36-CZ进行中（未招募）不适用
Intravenous low-dose decitabine versus supportive care in elderly patients withprimary Myelodysplastic Syndrome (MDS) (>10 % blasts or high-risk cytogenetics),secondary MDS or Chronic Myelomonocytic Leukemia (CMML) who are noteligible for intensive therapy: an EORTC-German MDS Study Group randomizedphase III study
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 220 人开始时间: 2005年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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 aged 60 years and older with either:
- •? primary MDS without any pretreatment
- •? primary MDS pretreated with either growth factors, immunosuppressive
- •agents or hydroxyurea. These drugs have to be stopped > 6 weeks before
- •randomisation.
- •? secondary MDS (previous radio-/chemotherapy for solid tumors or
- •and based on a BM aspiration or, in case of dry tap, on a BM biopsy, with either:
- •? Bone marrow blast count of 11-20%,
- •? Bone marrow blast count of = 10% with poor cytogenetics: any numerical or
- •structural abnormality of chromosome 7 and/or complex abnormalities (= 3
- •abnormalities)
- •? Bone marrow blast count of 21-30% (AML from MDS according to WHO
- •proposal, RAEB-t according to FAB) in centers not participating in the AML
- •elderly study of the EORTC. For these patients an observation period of one
- •month is necessary to exclude those patients with a rapid progression
- •towards full-blown AML.
- •NB: - The BM sample should be done within 3 weeks prior to randomization, the cytogenetics
- •examination should be done within 8 weeks prior to randomization, the blood sample
- •should be done within 1 week prior to randomization.
- •- Patients for whom the cytogenetic examination was unsuccesful (this means that
- •cytogenetic examination has been performed on BM or on blood material, but that the
- •result was considered as a failure; ex: NN with < 10 mitoses), may be included in this
- •trial, provided that the % of BM blasts is =5 % and/or 2-3 cytopenias are present.
- •? Absence of blast crisis of chronic myeloid leukemia.
- •? Absence of t(8;21), alone or in combination with other abnormalities
- •? Absence of pretreatment for MDS or AML with chemotherapy other than hydroxyurea.
- •? Absence of active malignancy in previous three years with the exception of basal or squamous
- •cell skin cancer or cervical carcinoma in situ within two years of study registration.
- •? Ineligible for intensive chemotherapy (ex: an anthracycline and Ara-C)
- •? Performance status according to the WHO scale: 0, 1 or 2.
- •? Adequate renal and liver function: creatinine and bilirubin < 1.5 times the upper limit of normal.
- •? Absence of severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment,
- •congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease, where
- •New-York Heart Association (NYHA)
- •Class III: marked limitation of activity; less than ordinary activity results in symptoms
- •Class IV: unable to carry on any physical activity without discomfort; symptoms at rest.
- •? HIV negative and HBsAg negative.
- •? Absence of active uncontrolled infection.
- •? No prior history or current evidence of central nervous system and psychiatric disorders
- •requiring hospitalization.
- •? Absence of any psychological, familial, sociological or geographical condition potentially
- •hampering compliance with the study protocol and follow-up schedule; those conditions should
- •be discussed with the patient before registration in the trial.
- •? Before patient randomization, signed written informed consent must be given according to ICH
- •GCP, and national/local regulations.
- •N.B. Patients can be randomized only once in this trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- 另有 2 项未显示
排除标准
- 未提供
研究者
相似试验
已完成
2 期
Phase II study of low-dose intravenous decitabine in patients aged > 60 years with acute myeloid leukemia who are not eligible for standard induction chemotherapyC92.0Acute myeloblastic leukaemia [AML]DRKS00000069niversitätsklinikum Freiburg235
进行中（未招募）
1 期
10-day decitabine versus conventional chemotherapy (3+7”) followed by allografting in AML patients = 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study GroupEUCTR2014-001486-27-LTEuropean Organisation for the Research and Treatment of Cancer (EORTC)600
进行中（未招募）
1 期
10-day decitabine versus conventional chemotherapy (3+7”) followed by allografting in AML patients = 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study GroupAcute Myeloid Leukaemia (AML) in elderly population (equal or older than 60 years).MedDRA version: 17.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: HLTClassification code 10024291Term: Leukaemias acute myeloidSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 17.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: HLGTClassification code 10024324Term: LeukaemiasSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 17.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001486-27-PTEuropean Orgainzation for the Research and Treatment of Cancer (EORTC)600
进行中（未招募）
1 期
10-day decitabine versus conventional chemotherapy (3+7”) followed by allografting in AML patients = 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study GroupEUCTR2014-001486-27-FREuropean Orgainzation for the Research and Treatment of Cancer (EORTC)600
进行中（未招募）
1 期
10-day decitabine versus conventional chemotherapy (3+7”) followed by allografting in AML patients = 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study GroupEUCTR2014-001486-27-SKEuropean Orgainzation for the Research and Treatment of Cancer (EORTC)600