ALLG AML M16
ACTRN12611001112954
Treatment
Phase 2
Charities/Societies/Foundations,Leukaemia Foundation of Australia (LFA)
A/Prof Andrew Wei
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 .... Read more
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 .... Read more
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, pulmo .... Read more
No
Sample Size 98
Min. age 15 Years
Max. age 65 Years
Sex Both males and females
Condition category Previously untreated adult acute myeloid leukaemia (AML) with FLT3-ITD mutation.
Condition code Cancer
Intervention code Treatment: Drugs
The study will screen newly diagnosed AML patients aged 15-65 for the presence of the FLT3-ITD mutation. Based on power calculations, 99 patients with FLT3-ITD will be randomized 2:1 to receive Sorafenib or placebo on days 4-10 of induction (1-2 x 28 day cycles), days 4-10 of consolidation (2 x 28 day cycles) and then for 12 months as maintenance therapy. Patients with suspected AML (WHO 2008 classification) will be consented for standard preliminary study procedures, including centralized cytog .... Read more
Control group Placebo
The placebo tablets contain croscarmellose sodium, microcrystalline cellulose, hydroxypropylmethyl cellulose, sodium lauryl sulphate and magnesium stearate. The film-coat consists of hydroxypropylmethyl cellulose, polyethylene glycol, titanium dioxide and red iron oxide. The tablets have a red colour in appearance, a weight of 350mg, and a 10mm round shape.
Outcome: To determine 2 year event-free survival (EFS) in untreated adult AML (age 15-65) with FLT3 ITD mutation administered the FLT3 inhibitor Sorafenib compared to a placebo control group not receiving Sorafenib. The primary endpoint will be the Event-free survival (EFS), measured from the date of randomisation until the date of death from any cause, AML relapse or treatment failure. If the patient does not achieve a CR, EFS is defined as the point of progression or death, w .... Read more
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis