This phase II trial is investigating the role of the drug sorafenib, given in combination with intensive chemotherapy for the treatment of Acute Myeloid Leukaemia (AML).
This trial is treating patients with Acute Myeloid Leukaemia.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have been diagnosed with cancer, but have not received any treatment.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Use the hyperlinks, where available to access additional clinical trial information.
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)
Australasian Leukaemia and Lymphoma Group (ALLG)
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.
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.
Recruiting Hospitals Read More
Not Recruiting Hospitals Read More