NCT01497002已完成3 期
Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.
University of Leipzig1 个研究点 分布在 1 个国家目标入组 1,222 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,222
- 试验地点
- 1
- 主要终点
- Event free survival
研究概览
简要总结
Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy
详细描述
Measuring EFS depending on induction therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes with age > 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification
- •written informed consent
排除标准
- •pretreatment of leukemia
- •no informed consent
- •simultaneous inclusion in other studies
- •mental disability
- •contraindication for intensive chemotherapy
- •AML FAB M3
- •contraindication for allogeneic stem cell transplantation
- •restriction of following organ functions:
- •creatinine-clearance < 50 ml/min
- •cardiac ejection fraction < 40 %
- •severe pulmonary restriction
- •bilirubin > 2x ULN; SGOT and SGPT > 4x ULN
- •uncontrolled hypertension
- •severe uncontrolled metabolism disturbance
- •Karnofsky-performance-score < 70%
- •hepatitis C
- •other malignancy
- •age of unrelated donor >70 years and age of related donor >75 years
研究组 & 干预措施
standard arm
Active Comparator
standard treatment arm
干预措施: Cytarabine (Drug)
OSHO - intensified consolidation
Experimental
Intermediate dose AraC
干预措施: Cytarabine (Drug)
OSHO - allografting as consolidation
Experimental
allogeneic stem cell Transplantation versus no transplantation
干预措施: human stem cells (Biological)
结局指标
主要结局
Event free survival
时间窗: after 5 years
comparison of event free survival (OSHO arm versus Standard intergroup arm)
次要结局
- LFS(at 5 years)
- OS(at 5 years)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
The AML18 Trial is an intensive chemotherapy trial for patients primarily over the age of 60 with AML and High Risk Myelodysplastic disease. This randomised, up to 2000 patient trial will evaluate the effect of adding novel treatment combinations to standard chemotherapy.Acute Myeloid LeukaemiaHigh Risk Myelodysplastic SyndromeMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2013-002730-21-GBCardiff University2,000
进行中（未招募）
1 期
The AML18 Trial is an intensive chemotherapy trial for patients primarily over the age of 60 with AML and High Risk Myelodysplastic disease. This randomised, up to 2000 patient trial will evaluate the effect of adding novel treatment combinations to standard chemotherapy.Acute Myeloid LeukaemiaHigh Risk Myelodysplastic SyndromeMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2013-002730-21-DKCardiff University2,000
Unknown
2 期
Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML PatientsAcute Myeloid LeukemiaNCT03045627Shandong University120
已完成
不适用
Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.Multiple myelomaNL-OMON25578Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl420
已完成
不适用
Randomized phase III trial in elderly patients with previously untreated symptomatic Multiple Myeloma comparing MP-Thalidomide (MP-Thal) followed by thalidomide maintenance versus MP-Lenalidomide (MP-Len) followed by maintenance with lenalidomide.Multiple MyelomaNL-OMON25186Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data Center; Erasmus MC; Postbus 2040; 3000 CA Rotterdam Tel: +31 10 704 1560; Fax +31 10 704 1028 e-mail: hdc@erasmusmc.nl668