NCT00199095已完成4 期
Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
Goethe University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 1997年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life
研究概览
简要总结
The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL)
- •age > 65 years
- •written informed consent
- •Karnofsky > 50% (if not mainly caused by leukemia)
- •laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN
排除标准
- •severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol
- •severe psychiatric illness or other circumstances which may compromise cooperation
- •active second neoplasia
- •clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy
结局指标
主要结局
Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life
次要结局
未报告次要终点
研究者
Nicola Goekbuget
Head of GMALL
Goethe University
研究点 (2)
Loading locations...
相似试验
已完成
4 期
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic LeukemiaAdult Acute Lymphocytic LeukemiaNCT00198978Goethe University377
进行中（未招募）
不适用
Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With CancerSolid NeoplasmNCT02517034City of Hope Medical Center600
已完成
不适用
Drug Reduction in Older Patients: The DROP TrialGeriatric AssessmentFrail ElderlySkilled Nursing FacilitiesPatient-centered CareNCT03722017VA Office of Research and Development260
已完成
2 期
Treatment of Older Patients With B-precursor ALL With Sequential Dose Reduced Chemotherapy and BlinatumomabB-Precursor ALLNCT03480438Goethe University52
招募中
3 期
CtDNA-guided Selection of Adjuvant Chemotherapy Regimens for Elderly Colon Cancer Patients After Surgery: a Single-center, Randomized, Controlled StudyColon Cancer (stage II &amp;amp; III)Colon CancerNCT06609551Zhejiang Cancer Hospital312