DRKS00024079招募中3 期
International multicenter, open-label clinical trial for the treatment of acute myeloid leukemia in children and adolescents - AIEOP-BFM-AML 2020
Gesellschaft für pädiatrische Onkologie und Hämatologie (GPOH)0 个研究点目标入组 1,050 人开始时间: 2022年10月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,050
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- one 至 21 Years（—）
- 性别
- All
入选标准
- •For all Groups:
- •Understand and voluntarily provide written permission of parental/legal representative(s) to the ICF prior to conducting any study related assessments/procedures, also concerning data and biomaterial transfer according to ICH/GCP and national/local regulations
- •Able to adhere to the study visit schedule and other protocol requirements
- •Negative serum pregnancy tests for females of child-bearing potential within 10 days prior to treatment
- •Diagnosis of an AML (according to WHO classification 2016)
- •Acute leukemia of ambiguous lineage (MPAL; according to WHO classification 2016: acute undifferentiated leukemia (AUL, bilineal leukemia; biphenotypic leukemia, dominant myelogenous; lineage switch)
- •Children and adolescents < 18 years of age at start of initial chemotherapy
- •Acceptance that vaccination with live vaccines is not possible
- •while participating in the trial
- •Patients with first relapsed (including relapse after SCT) or primary refractory AML
- •Children and adolescents < 18 years of age at start of initial chemotherapy and < 21 years of age at start of this relapsed AML treatment
- •Patients with AML and indication for first allogenic HSCT of an HLA-identical donor (at least high-resolution typing minimal 9/10,)
- •Age at time of inclusion from 1 month (28 days) to less than 18 years at diagnosis; up to 21 years at time of HSCT
- •criteria for allogeneic HSCT:
- •o in AML complete remission (CR)
- •o available MSD, MFD or MUD; matched is defined as at least 9/10 after 4 digit typing for HLA-A, B, C,DRB1, DQB1 loci
排除标准
- •All Groups:
- •Existing syndromes which exclude treatment including Fanconi anemia or chromosomal instability syndromes
- •Patients with trisomy 21 and ML-DS and/or transient myeloproliferative syndrome
- •Patients with an acute promyelocytic leukemia (APL), AML with t(15;17)
- •Treatment-related or secondary AML
- •Symptomatic cardiac dysfunction (CTCAE 5.0 Grade 3 or 4)
- •Any other organ dysfunction (CTCAE 5.0 Grade 3 or 4)
- •Evidence of invasive fungal infection or other severe systemic infection requiring treatment doses of systemic/parenteral therapy including known active viral infection with human immunodeficiency virus (HIV) or hepatitis type B and C
- •Participation in another clinical trial with an intervention interfering with the aims of this trial
- •Pregnant or breast-feeding patients
- •Female and male subjects with child-bearing potential who avoid using highly effective anticonceptive measure(ment)s
- •Hypersensitivity to the active substance or other excipients contained in the investigational medical product listed in the summary of product characteristics (SmPC) or Investigators Brochure (IB).
- •Previous-therapy with cytostatic medicines of more than 14 days and other than specified in protocol as allowed prephase
- •Diagnosed Wilson´s Disease
- •Fractional Shortening at echocardiography below 29%
- •A Karnofsky performance status < 40% (children = 16 years) or a Lansky performance status of < 40% (children < 16 years) before start of the first course
- •impaired liver function: Bilirubin > 3 times upper normal limit; transaminases > 3 times upper normal limit
- •History of VOD
- •Renal impairment with creatinine < 30 ml/min
- •Decompensated haemolytic anaemia
- •A Karnofsky performance status < 60% (children = 16 years) or a Lansky performance status of < 60% (children < 16 years) before start of the Group treatment
- •treatment with cytotoxic drugs within 10 days prior to planned study drug administration
- •impaired liver function: Bilirubin = 3 times upper normal limit; transaminases = 5 times upper normal limit
- •renal impairment with creatinine <30 ml/min
- •Cardiac insufficiency requiring treatment; LVEF = 35% (for patients with history of cardiac disease or anthracycline exposure)
- •Impaired pulmonary function: PO2 = 70 mm Hg or DLCO = 60%
- •requirement of supplementary continuous oxygen
- •symptomatic involvement of CNS: leukemic infiltration not cleared by prior intrathecal chemotherapy and/or cranial radiotherapy
- •other disease, comorbidity or condition that would severely limit life expectancy
研究者
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