Dettagli per singolo studio

DEC-NET Serial number FR546

Published online	10/07/2006 16.52.00
Last updated	14/12/2006 15.41.45

Other protocol ID number	N/A
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	MYELOID LEUKEMIA ACUTE
Experimental drug
DAUNORUBICIN Treatment regimen (dosage and duration) -
Gender	Both
Age (range)	under 18 years
Eligibility criteria
Inclusion criteria
-Children and adolescents <18 years of age at start of chemotherapy -Primary refractory AML -First relapsed AML -Patients with a second or subsequent relapsed AML that were not previously treated according to this particular protocol -Signed written informed consent
Exclusion criteria
-Symptomatic cardiac dysfunction (CTC grade 3 or 4) and/or a Fractional Shortening at echocardiography below 29% -A Karnofsky performance status <40% (children >=16 years) or an Lanksy performance status of <40% (children < 16 years) before start of chemotherapy -Any other organ dysfunction (CTC grade 4) that will interfere with the protocol treatment -Inability to potentially complete the treatment protocol for any other reason -FAB type M3,acute promyelocytic leukemia, and/or t(1517) and /or PML-RARalfa fusion gene.
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety Pharmacokinetics
Design	Controlled Randomised
Purpose of study
Primary :in a large group of children with refractory and relapsed acute myeloid leukemia -To determine the efficacy of liposomal daunorubicin (DaunoXome®) when added to FLAG in the 1st course as compared to patients treated with FLAG only. Secondary : -To determine the toxicity of DaunoXome® when added to FLAG, in terms of mucosal toxicity, bone marrow aplasia, short- and long-term cardiotoxicity and other side effects,as compared to patients treated with FLAG only. -Determine the long-term clinical outcome prospectively
Primary outcomes
Percentage of bone marrow blasts (yes or no >20%) after one block of Chemotherapy (FLAG or FLAG/DaunoXome)
Secondary outcomes
-Toxicity -Efficacy
Summary of study design, objectives, and ongoing research findings
It is an international multicenter open label randomised phase III trial in children with relapsed and refractory acute myeloid leukemia (AML). Reinduction treatment will be done with 2 courses of combination chemotherapy, with FLAG (fludarabine, ara-C and G-CSF) in both courses as standard treatment. In the first course there will be a randomisation for liposomal daunorubicin (DaunoXome) to be added or not. The main end point is the percentage of BM blasts (yes or no >20%) after one block of Chemotherapy (FLAG or FLAG/DaunoXome), which will be compared between both arms. Main objectives of the study are to determine the efficacy and toxicity of DaunoXome when added to FLAG in children with relapsed and refractory AML. In addition, the study will prospectively determine the clinical outcome of these patients, stratified according to the different risk groups (refractory disease, early relapse, late relapse, multiple relapse). The study expects to accrue up to 100 patients annually, and will run about 4 years.