Prospective, multi-center, interventional, randomized, open clinical trial for the treatment of acute myeloid leukemia with FLT3 mutations customized upon the prognostic parameter PBC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
100 mg/m2/bid day 1-3 100 mg/m2/die day 4-7
60 mg/m2/die day 1-3
50 mg/bid day 8-21
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
Event Free Survival
Improvement of outcome measured as event-free survival (EFS) in patients with FLT3+ acute myeloid leukemia who are predicted to have low chemosensitivity, as defined upon the biomarker "peripheral blast clearance (PBC)", following the application of an early intensification of overall treatment, both in induction (high-doses delivery) and in consolidation (allocation to allogeneic transplant) phase, compared with standard regimens
Time frame: 2,5 years
Adverse events rate
Adverse events rate according to CTCAE criteria
Time frame: 2,5 years
Rate of death in aplasia
rate of death in aplasia
Time frame: 2 months
Neutrophil recovery
Median number of days for neutrophil recovery
Time frame: 2 months
platelet recovery
Median number of days for platelet recovery
Time frame: 2 months
CR rate
Complete remission rate after induction
Time frame: 6 months
DFS
Disease-free survival
Time frame: 2 years
OS
Overall survival
Time frame: 2 years
CIR
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100 mg/m2/bid day 1-3 100 mg/m2/die day 4 1.500 mg bid day 5-7
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
Bari, Italy
RECRUITINGAou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, Italy
RECRUITINGAsst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, Italy
RECRUITINGAou Careggi- Sod Ematologia
Florence, Italy
RECRUITINGAsl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
Latina, Italy
RECRUITINGAsl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce, Italy
RECRUITINGAulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
Mestre, Italy
RECRUITINGAou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano, Italy
RECRUITINGAo Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo, Italy
RECRUITING...and 10 more locations
Cumulative incidence of relapse
Time frame: 2 years
MRD assessment
MRD negativity rate at the end of induction and consolidation
Time frame: 6 months