Trial purpose
Cancer treatment
Tumor type
Haematological
Age
15 - 65
Trial acronym
ALLG AML M16
Clinical summary
Summary
This study aims to determine the safety and efficacy of treatment with the drug Sorafenib, in combination with intensive chemotherapy for adults with previously untreated acute myeloid leukaemia (AML). Who is it for? You may be eligible to join this study if you are aged between 15-65 years and have been diagnosed with AML with FLT3-ITD mutation. You must have received no previous treatment for AML. Trial details All participants in this trial will undergo intensive chemotherapy over a period of minimum twelve months. Participants will be randomly (by chance) allocated to one of two groups. One group will receive the oral drug Sorafenib whilst undergoing chemotherapy and for a period of 12 months afterwards. The other group will receive a placebo (inactive) treatment in conjunction with chemotherapy. Participants will not know which group they are in until completion of the trial. Participants will be assessed at regular timepoints for a period of up to 5 years to determine the safety and clinical benefit of Sorafenib treatment in combination with chemotherapy. Treatment Duration will be a minimum of 1 year. This Phase II study will: Investigate the clinical benefit of frontline Sorafenib in combination with chemotherapy and during maintenance therapy in adult AML Optimise the dosing schedule of Sorafenib based on the kinetics of circulating FLT3 ligand levels after chemotherapy Investigate the clinical benefit of Sorafenib in relation to additional molecular AML lesions Identify pharmacokinetic and pharmacodynamic correlates of response predictive of treatment outcome.
Conditions
This trial is treating people with Acute Myeloid Leukaemia
Eligibility
Inclusion
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
Exclusion
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.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australasian Leukaemia and Lymphoma Group (ALLG)
Scientific Title
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 (Other ID's: U1111-1122-6056)
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