NCT01237808已完成3 期
Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation
University of Ulm33 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2011年3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
- 144
- 试验地点
- 33
- 主要终点
- overall survival
研究概览
简要总结
This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy.
Sample size: 144 patients
Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are expected to be included into the trial)
Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient will last additional 2 years)
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
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML)
- •Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories.
- •Age > 60 years. There is no upper age limit.
- •No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 10 days during the diagnostic screening phase.
- •Signed written informed consent
- •Men must give their informed consent that they do not father a baby and must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy. (while on therapy and for 3 month after the last dose of chemotherapy)
- •WHO performance status ≤ 3
- •Patients not eligible for intensive chemotherapy according to at least one of the following criteria
- •HCT-CI Score >2
- •Patient's decision
- •age ≥ 75 years
排除标准
- •The presence of any of the following will exclude a patient from study enrollment:
- •All other AML subtypes, in particular those AML with other recurrent genetic changes (according to WHO 2008):
- •AML with t(8;21)(q22;q22); RUNX1-RUNX1T1
- •AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
- •AML with t(15;17)(q22;q12); PML-RARA (or other translocations involving RARA)
- •AML with t(9;11)(p22;q23); MLLT3-MLL (or other translocations involving MLL)
- •AML with t(6;9)(p23;q34); DEK-NUP214
- •AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
- •No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about study participation
- •Bleeding disorder independent of leukemia
- •Uncontrolled infection
- •Known positive for HIV, HBV or HCV
- •Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or ALP >2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
- •Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
- •Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
研究组 & 干预措施
Standard arm
Active Comparator
6 cycles of chemotherapy (low-dose cytarabine and etoposide) without ATRA
干预措施: Cytarabine (Drug)
Standard arm
Active Comparator
6 cycles of chemotherapy (low-dose cytarabine and etoposide) without ATRA
干预措施: Etoposide (Drug)
Investigational arm
Experimental
6 cycles of chemotherapy (low-dose cytarabine and etoposide) with ATRA (All-trans-Retinoic acid)
干预措施: Cytarabine (Drug)
Investigational arm
Experimental
6 cycles of chemotherapy (low-dose cytarabine and etoposide) with ATRA (All-trans-Retinoic acid)
干预措施: Etoposide (Drug)
Investigational arm
Experimental
6 cycles of chemotherapy (low-dose cytarabine and etoposide) with ATRA (All-trans-Retinoic acid)
干预措施: All-trans retinoic acid (ATRA) (Drug)
结局指标
主要结局
overall survival
时间窗: 2 years and 8 months
次要结局
- Rate of Complete remission(8 months)
- cumulative incidence of relapse(2 years and 8 months)
- cumulative incidence of death in complete remission(2 years and 8 months)
- event-free survival(2 years and 8 months)
- Rate of early deaths (ED)/hypoplastic deaths (HD)(8 months)
- Type, frequency, severity, timing and relatedness of adverse events (AEs) and laboratory abnormalities observed during different treatment cycles(8 months)
- Incidence of infection after each treatment cycle(8 months)
- Duration of neutropenia after each treatment cycle(8 months)
- Duration of thrombocytopenia after each treatment cycle(8 months)
- Duration of hospitalization after each treatment cycle(8 months)
- Quality of life(2 years and 8 months)
研究者
Prof. Dr. Hartmut Doehner
Prof. Dr.
University of Ulm
研究点 (33)
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