NCT00893399已完成3 期
Phase III Study of Chemotherapy in Combination With ATRA With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia and NPM1 Gene Mutation
University of Ulm60 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2010年5月12日最近更新:
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
- 600
- 试验地点
- 60
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Randomized Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation.
Before Amendment No. 4 (December 2013):
Primary Efficacy Objective:
- Evaluation of efficacy based on event-free survival (EFS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1)
After Amendment No. 4 (December 2013):
Primary Efficacy Objective:
- Evaluation of efficacy based on overall survival (OS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1)
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 —（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.
- •Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories.
- •Age ≥ 18 years. There is no upper age limit.
- •No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 5 days during the diagnostic screening phase.
- •Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration.
- •Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and within one year after the last dose of chemotherapy.
- •Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control: one highly effective method (e.g., IUD, hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap).
- •"Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
- •Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy.
- •Signed written informed consent.
排除标准
- •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-EVI
- •Performance status WHO >
- •Patients with ejection fraction < 50% by MUGA or ECHO scan within 14 days of day
- •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.
- •Uncontrolled infection.
- •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.
- •Known positive for HIV, active HBV, HCV, or Hepatitis A infection.
- •Bleeding disorder independent of leukemia.
- •No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
研究组 & 干预措施
1
Experimental
chemotherapy in combination with ATRA with gemtuzumab ozogamicin
干预措施: Gemtuzumab Ozogamicin (Mylotarg) (Drug)
1
Experimental
chemotherapy in combination with ATRA with gemtuzumab ozogamicin
干预措施: standard chemotherapy (Drug)
2
Active Comparator
chemotherapy in combination with ATRA without gemtuzumab ozogamicin
干预措施: standard chemotherapy (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: four years
次要结局
- Days in hospital during each cycle and during the whole intervention(6 months)
- Incidence of infection after induction and consolidation therapy(6 months)
- Rates of complete remission after induction therapy (CR)(not later than 56 days)
- Cumulative incidences of relapse (CIR) and death in CR (CID)(four years)
- Event-free survival (EFS)(four years)
- Type, frequency, severity, timing and relatedness of AEs and laboratory abnormalities observed during different treatment cycles(6 months)
- Duration of neutropenia and thrombocytopenia after induction and consolidation therapy(6 months)
- Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics according to Messerer et al [49](two years after completion of therapy)
研究者
Prof. Dr. Hartmut Doehner
Prof. Dr.
University of Ulm
研究点 (60)
Loading locations...
相似试验
已完成
2 期
Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung CancerNon-small Cell Lung CancerSquamous Cell CarcinomaNCT01631357Tianjin Medical University Cancer Institute and Hospital96
已完成
3 期
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard ChemotherapyAcute Myeloid Leukemia (AML)Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) MutationNCT02752035Astellas Pharma Global Development, Inc.183
已完成
3 期
PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural MesotheliomaPleural Mesothelioma Malignant AdvancedNCT02991482ETOP IBCSG Partners Foundation144
进行中（未招募）
1 期
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML)FLT3-mutated Acute Myeloid LeukemiaNCT05520567Astellas Pharma Global Development, Inc.70
招募中
2 期
A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLCNon Small Cell Lung CancerNCT06424899Zeng Jian92