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临床试验/ISRCTN78449203
ISRCTN78449203已完成3 期

Adults with Acute Myeloid Leukaemia or High-Risk Myelodysplastic Syndrome (AML19): a randomised, controlled, open label Phase III trial

Cardiff University (UK)0 个研究点目标入组 1,033 人开始时间: 2014年12月8日最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
1,033
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2023 Results article in https://doi.org/10.1182/bloodadvances.2023010276 (added 15/05/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38215358/ (added 15/01/2024)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •Current participant inclusion criteria as of 25/02/2021:
  • •1. One of the forms of CD33 positive (any level), favourable, standard risk or unknown cytogenetics de novo AML as defined by theWHO Classification
  • •2. WHO performance status 0-2
  • •3. Considered suitable for intensive chemotherapy
  • •4. Aged 16 to 60 years with the following caveats:
  • •4.1. If intensive therapy is considered a suitable option those aged >60 years are eligible
  • •4.2. To receive midostaurin: aged =18 years
  • •5. A negative pregnancy test within 2 weeks prior to trial entry in WOCBP to be repeated throughout the trial prior to each course of protocol treatment
  • •6. Sexually active participants must agree to use an adequate and medically accepted method of contraception throughout the study, and for 6 months following treatment (female participants receiving Mylotarg should continue for 7 months following treatment), if they, or their sexual partners, are women of childbearing potential (WOCBP)
  • •7. Written informed consent provided
  • •8. Patients must have Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) =2.5 × upper limit of normal (ULN) and bilirubin =2 × ULN
  • •9. To receive midostaurin: FLT3-TKD or FLT3-ITD mutation detected by the central laboratory in Cardiff
  • •Previous participant inclusion criteria:
  • •AML Patients:
  • •1. They have one of the forms of acute myeloid 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 >10% bone marrow blasts)
  • •2. Patients with acute promyelocytic leukaemia (APL) are eligible and should be entered into the randomisations specifically for APL (see Section 9)
  • •3. They are considered suitable for intensive chemotherapy
  • •4. They should normally be 18 years up to the age of 60, but patients over this age are eligible if = intensive therapy is considered a suitable option
  • •5. The serum creatinine should be = 1.5 × ULN (upper limit of normal)
  • •6. Patients eligible for the Mylotarg randomisation must have Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) =2.5 × ULN and bilirubin =2.× ULN (Note: Patients who do not comply with the liver inclusion criteria are eligible to enter the trial but will be excluded from the Mylotarg randomisation)
  • •7. 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). Similarly women must agree to adequate contraceptive measures. This applies to APL and AML patients. In both males and females these measures must be in place for at least 30 days after the last administration of ganetespib
  • •8. They have given written informed consent
  • •APL Patients:
  • •1. They have provided signed written informed consent (PIS 3)
  • •2. They have a morphological diagnosis of APL (if cytogenetic or molecular diagnosis is not confirmed patients will transfer to the non-APL treatments)
  • •3. They should be over 18 years
  • •4. They have WHO performance status 0-2
  • •5. Their serum total bilirubin is < 2.0 mg/dL (=51 µmol/L)
  • •6. Their serum creatinine is < 3.0 mg/dL (< 260 µmol/L)

排除标准

  • •Current participant exclusion criteria as of 25/02/2021:
  • •1. Patients with APL, secondary AML, therapy-related AML, high-risk myelodysplastic syndrome with <20% bone marrow blasts, or de novo AML with known adverse risk cytogenetics
  • •2. Patients who 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.
  • •3. Blast transformation of chronic myeloid leukaemia (CML)
  • •4. Concurrent active malignancy requiring treatment
  • •5. Pregnant or lactating
  • •Previous participant exclusion criteria:
  • •Patients are not eligible for the AML arms of the AML19 trial if:
  • •1. 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.]
  • •2. They have received demethylation therapy for AML or high risk MDS defined as marrow blasts >10%. Patients treated for lower risk MDS who progress to AML are eligible
  • •3. They are in blast transformation of chronic myeloid leukaemia (CML)
  • •4. They have a concurrent active malignancy requiring treatment
  • •5. They are pregnant or lactating
  • •6. The physician and patient consider that intensive therapy is not an appropriate treatment option
  • •7. Known infection with Human Immunodeficiency Virus (HIV)
  • •8. Patients with AST or ALT more than 2.5 times the local upper limit of normal or Bilirubin more than twice upper limit of normal, are not eligible for the Mylotarg randomisations
  • •For Ganetespib randomisation there are specific cardiac exclusions:
  • •1. A myocardial infarction within 12 months
  • •2. Uncontrolled angina within 6 months
  • •3. Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is = 45% (or institutional lower limit of normal value)
  • •4. Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes [TdP]) or any history of arrhythmia will be discussed with the Clinical Coordinator/Safety Physician prior to patient?s entry into the study
  • •5. Prolonged QTcF interval on pre-entry ECG (=450 ms)
  • •6. Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker
  • •7. Heart rate <50/minute on pre-entry ECG
  • •8. Uncontrolled hypertension
  • •9. Obligate need for a cardiac pacemaker
  • •10. Complete left bundle branch block
  • •11. Atrial fibrillation
  • •APL Patients:
  • •1. They are aged < 18
  • •2. They have an active malignancy requiring treatment at time of study entry
  • •3. There is a lack of subsequent diagnostic confirmation of PML-RARA fusion at molecular level
  • •4. Known infection with Human Immunodeficiency Virus (HIV)
  • •5. Significant arrhythmias, ECG abnormalities or neuropathy are apparent
  • •6. Severe uncontrolled pulmonary or cardiac disease is apparent
  • •7. They are pregnant or lactating

研究者

发起方
Cardiff University (UK)

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