Sorafenib in combination with intensive chemotherapy for previously untreated adult FLT3-Internal Tandem Duplication (FLT3-ITD) - positive AML: A Phase II randomised placebo-controlled multi-centre study evaluating two year progression-free survival

eukaemia Foundation of Australia0 个研究点目标入组 98 人开始时间: 2011年10月25日最近更新: 2023年8月21日

适应症

试验速览

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•A morphological diagnosis of AML by WHO 2008 criteria, confirmed by special stains, immunophenotyping and, if available, cytogenetics. All clinico-pathological subtypes will be eligible, except for AML with t(15;17) or variants.
•Patients with secondary and therapy related AML are eligible
•FLT3-ITD mutation with an allelic mutant:wild-type ratio of = 0.05
•Age 15 to 65 years inclusive.
•ECOG performance status 0 to 2 inclusive
•Absence of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine <1.5 times the upper limit of normal (ULN) and serum bilirubin < 2.5 times the upper limit of normal, is required for eligibility
•Normal left ventricular ejection fraction, according to institutional criteria.
•No previous treatment for AML or history of cancer (other than basal cell skin cancer or carcinoma of the cervix in situ, or other localised cancer treated by surgical excision only more than 5 years earlier without evidence of recurrence in the intervening period)
•No contraindication to the use of the study drugs
•Treatment must be given at an affiliated ALLG centre, with approval of the protocol by the institution’s Human Research Ethics Committee, or equivalent body
•Written informed consent must be obtained from each patient prior to registration and start of treatment

•Clinically active CNS leukaemia
•Prior chemotherapy for AML (other than hydroxyurea ceased at least 24 hrs prior)
•Known HIV positive
•Known active hepatitis B or C, or any other active liver disease
•Patients with parenchymal abnormality on screening chest x-ray must have no evidence of pulmonary infection on chest tomography (CT) prior to starting remission induction therapy
•Any major surgery or radiation therapy within 4 weeks prior to study entry
•Serious concomitant illnesses (for example, pulmonary infiltrate, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart failure AHA class 2 or greater, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.), which in the investigator’s opinion would not make the patient a good candidate for the trial
•Pregnant or breastfeeding
•Any other known condition (e.g., familial, sociological, or geographical) or behaviour (including substance dependence or abuse, psychological or psychiatric illness), which in the investigator’s opinion would make the patient a poor candidate for the trial.

发起方

eukaemia Foundation of Australia