AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance
NCT ID: NCT04174612
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
172 participants
INTERVENTIONAL
2020-04-24
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard clinical treatment
Patients will complete "3+7" + Midostaurin induction course.
Cytarabine
100 mg/m2/bid day 1-3 100 mg/m2/die day 4-7
Daunorubicin
60 mg/m2/die day 1-3
Midostaurin
50 mg/bid day 8-21
Experimental treatment
The experimental arm will provide 2 main modifications compared to standard:
i) immediate switch to intensified induction with high-doses Cytarabine (on days 5, 6 and 7 of induction) ii) early allocation to high-risk disease category to be refined according to ELN stratification and post induction MRD status
Daunorubicin
60 mg/m2/die day 1-3
Midostaurin
50 mg/bid day 8-21
Cytarabine HD
100 mg/m2/bid day 1-3 100 mg/m2/die day 4 1.500 mg bid day 5-7
Interventions
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Cytarabine
100 mg/m2/bid day 1-3 100 mg/m2/die day 4-7
Daunorubicin
60 mg/m2/die day 1-3
Midostaurin
50 mg/bid day 8-21
Cytarabine HD
100 mg/m2/bid day 1-3 100 mg/m2/die day 4 1.500 mg bid day 5-7
Eligibility Criteria
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Inclusion Criteria
2. Presence of a mutation of FLT3 gene, either ITD and/or TKD
3. Adequate availability of diagnostic biologic material for full cytological, cytogenetic, genetic and immunophenotypic disease characterization according to ELN criteria.
4. Presence of morphologically identifiable blasts on peripheral blood at diagnosis
5. Presence of a Leukemia-associated aberrant immune-phenotype (LAIP) as assessed by MFC (multiparametric flow cytometry) at diagnosis
6. Age between 18 and 65 years, included
7. ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.
8. Signed written informed consent according to ICH/EU/GCP and national local laws
Exclusion Criteria
2. Diagnosis of AML with t(8;21)(q22:q22)/RUNX1-RUNX1T1 and t(16;16)(p13:q22) or inversion of chromosome 16 (16)(p13q22)/CBFB-MYH11; in case of suspicion of CBF-related AML due to morphological and/or immunophenotypic features, specific FISH or molecular testing is strongly recommended in accordance with WHO criteria3,157
3. Patients with LVEF less than 45% (by echocardiogram or MUGA)
4. Pre-existing, uncontrolled pathology such as heart failure (congestive/ischaemic, acute myocardial infarction within the post 3 months, untreatable arrhythmias, NYHA classes III and IV), sever liver disease with total bilirubin ≥2,5 x ULN and/or ALT\>3 ULN (unless attributable to AML), acute or chronic pancreatitis, kidney function impairment with serum creatinine ≥2,5 (unless attributable to AML) and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent or to cope with the intended treatment plan. For altered liver, pancreas and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
5. Uncontrolled bacterial or fungal infections
6. QTc \>470 msec on screening ECG (Fridericia's formula)
7. A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy \< 1 year.
8. Pregnancy declared by the patient herself. A pregnancy test is performed at diagnosis and, if applicable, before allogeneic HSCT . Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 4 months after the end of treatment.
18 Years
65 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Locations
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Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, , Italy
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
Bari, , Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, , Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, , Italy
Aou Careggi- Sod Ematologia
Florence, , Italy
Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
Latina, , Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce, , Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
Mestre, , Italy
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano, , Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo, , Italy
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
Palermo, , Italy
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
Pavia, , Italy
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
Ravenna, , Italy
Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
Reggio Calabria, , Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, , Italy
C.R.O.B. - I.R.C.C.S. - Rionero in Volture - Uoc Ematologia
Rionero in Vulture, , Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
Roma, , Italy
Aou Senese - Uoc Ematologia E Trapianti
Siena, , Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino, , Italy
Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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Vannucchi
Role: primary
Other Identifiers
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AML1919
Identifier Type: -
Identifier Source: org_study_id
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