EUCTR2013-002730-21-GB进行中（未招募）1 期
A Trial for Older Patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome - AML18
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are eligible for the AML18 trial if:
- •They have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia as defined by the WHO Classification (Appendix A) this can be any type of de novo or secondary AML – or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2). (NB patients with prior MDS (>10% blasts, RAEB2) who have received prior azacitidine are not eligible for the trial, but patients with <10% who have failed a hypomethylating agent and developed AML may enter the trial)
- •Patients should normally be over the age of 60, but patients under this age are eligible if they are not considered eligible for the MRC AML19 trial. Please contact the trial team for further information
- •Patients entering the Vosaroxin/Decitabine arm must be over the age of 60 and have known adverse risk cytogenetics at entry
- •They have given written informed consent
- •Serum creatinine = 1.5 × ULN (upper limit of normal)
- •Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP). Men should be advised to not father a child while receiving trial treatment. Similarly women must agree to adequate contraceptive measures and avoid becoming pregnant while on protocol treatment. In both males and females these measures must be in place for at least 3 months following completion of Decitabine and at least 6 months after the last administration of Cladribine. The time period following treatment with Decitabine where it is safe to become pregnant is unknown. In the event of pregnancy at any point during the trial, the IMPs should be immediately stopped and the Trial Team should be contacted and pregnancy reporting procedures followed
- •ECOG Performance Status of 0-2
- •Please note for the AC220 intervention: specific electrolyte and cardiac criteria (see page 29) must be met. Only patients with a confirmed FLT3 mutation in the diagnostic sample are eligible for the AC220 randomisation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 750
排除标准
- •Patients are not eligible for the AML18 trial if:
- •They have previously received cytotoxic chemotherapy for AML
- •[Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy, is not an exclusion]
- •They are in blast transformation of chronic myeloid leukaemia (CML)
- •They have a concurrent active malignancy excluding basal cell carcinoma
- •They are pregnant or lactating
- •They have Acute Promyelocytic Leukaemia
- •Known infection with human immunodeficiency virus (HIV)
- •Patients with prior cumulative anthracycline exposure (from prior treatment of a non AML cancer) of greater than 300 mg/m2 daunorubicin (or equivalent).
- •History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before entry
- •Patients with known adverse risk cytogenetics are excluded from entering the AML18 trial unless they are registered to receive vosaroxin and decitabine
- •Specific exclusion criteria for the Mylotarg Arm
- •Pre-existing liver impairment with known cirrhosis
- •Total bilirubin > 1.5 x the upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) > 2.5 x ULN
- •Alanine aminotransferase (ALT) > 2.5 x ULN
- •Specific exclusion criteria for the Vosaroxin/Decitabine Arm
- •Total bilirubin > 1.5 x the upper limit of normal (ULN),
- •Aspartate aminotransferase (AST) > 2.5 x ULN
- •Alanine aminotransferase (ALT) > 2.5 x ULN
- •Left ventricular ejection fraction (LVEF) < 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)]
- •Specific exclusion criteria for CPX-351 treatment
- •Hypersensitivity to cytarabine, daunorubicin or liposomal products
- •History of Wilson’s disease or other copper-metabolism disorder
- •Specific exclusion criteria for Cladribine
- •Patient’s serum creatinine must be within the local ULN to enter the randomisation. Patients for whom this is not the case can be randomised between the remaining options.
- •In addition patients are not eligible for the AC220 randomisation if they have:
- •Cardiovascular System Exclusion Criteria:
- •Known serious cardiac illness or medical conditions, including but not limited to:
- •I.Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker
- •II.Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted.
- •III.Use of medications that have been linked to the occurrence of torsades de pointes (see Appendix B for the list of such medications)
- •IV.Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker
- •V.Complete left bundle branch block (LBBB)
- •VI.History of long QT Syndrome or a family member with this condition
- •VII.Serum potassium, magnesium, and calcium levels outside the laboratory’s reference range
- •VIII. QTc >450 ms (average of triplicate ECG recordings); a consistent method of QTc calculation must be used for each patient’s QTc measurements. QTcF (Fridericia’s formula) is preferred. Please see the trial website for QTcF calculator.
研究者
相似试验
进行中（未招募）
1 期
The AML18 Trial is an intensive chemotherapy trial for patients primarily over the age of 60 with AML and High Risk Myelodysplastic disease. This randomised, up to 2000 patient trial will evaluate the effect of adding novel treatment combinations to standard chemotherapy.Acute Myeloid LeukaemiaHigh Risk Myelodysplastic SyndromeMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2013-002730-21-DKCardiff University2,000
已完成
不适用
Investigational study for elderly acute myelocytic leukemiaacute myelocytic leukemiaJPRN-C000000224Japan Adult Leukemia Study Group288
招募中
不适用
Treatment outcome in elderly patients with acute myeloid leukemia at Siriraj HospitalThe patients 60 years and older who were diagnosed and know to have acute myeloid leukemia.Treatment outcome in elderly patients with acute myeloid leukemia at Siriraj HospitalTCTR20210514007Siriraj Hospital Mahidol University400
Unknown
不适用
Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and SurvivalAcute Myeloid LeukemiaNCT01188330Institut Paoli-Calmettes100
进行中（未招募）
不适用
A phase III trial in adult acute myelogenous leukemia AML comparing 1 standard-dose versus high-dose remission induction therapy and 2 , within a risk-oriented postremission strategy, an autologous blood stem cell transplantation versus an autologous blood stem cell-supported multicycle high-dose program Protocol NILG-AML 02/06 . - NDPATIENT WHIT LMAMedDRA version: 8.1Level: HLTClassification code 10024291Term: Leukaemias acute myeloidEUCTR2006-003817-42-ITAZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO A.O. DI RILIEVO NAZIONALE