International randomized phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukemia

Hannover Medical School0 个研究点目标入组 252 人开始时间: 2014年2月4日最近更新: 2014年3月10日

适应症

试验速览

暂无简介。

•1. Children and adolescents < 18 years of age at start of initial chemotherapy and < 21 years of age at start of this relapsed AML treatment
•2. Patients with first relapsed (including relapse after SCT) or primary refractory AML
•3. Signed written informed consent from patients and/or from parents or legal guardians for minor patients, according to local law and regulations
•4. In female patients of childbearing potential pregnancy must be excluded.
•5. Sexually active patients must be using two reliable contraception methods from the time of screening/baseline and during the study for a minimum of 3 months after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 315
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Acute promyeloblastic leukemia (AML FAB type M3; please refer to your local group for the appropriate treatment protocol)
•2. Myeloid Leukemia of Down syndrome (please refer to your local group for treatment alternatives)
•3. Symptomatic cardiac dysfunction (CTCAEv4 grade 3 or 4) and/or a Fractional Shortening at echocardiography below 29%
•4. A Karnofsky performance status < 40% (children = 16 years) or an Lansky performance status of < 40% (children < 16 years) before start of chemotherapy
•5. Any other organ dysfunction (CTCAEv4 grade 4) that will interfere with the administration of the therapy according to this protocol
•6. Impaired liver function defined as > 3.0 x UNL for transaminases and for bilirubin
•7. History of VOD
•8. History hepatitis C positivity
•9. Renal impairment with creatinine < 30 ml/min
•10. Decompensated hemolytic anemia
•11. Hypersensitivity to GO and/or other chemotherapeutic drugs
•12. Inability to potentially complete the treatment protocol for any other reason
•13. Pregnant or breastfeeding patients
•14. Current participation in another clinical trial for the time of first course of reinduction chemotherapy

发起方