The purpose of this study is to determine whether a risk-adapted, minimal-residual-disease
directed therapy for young adults with newly diagnosed acute myeloid leukemia has positive
results in terms of overall survival at 24 months.
Other: Risk-adapted, MRD-directed therapy
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01452646
Ages eligible for Study
18 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Signed written informed consent according to ICH/EU/GCP and national/local laws
Patients aged between 18 and 60 years
Patients previously untreated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days hydroxyurea (HU)), radiotherapy or more than 7 days corticosteroids
Unequivocal diagnosis of untreated de novo AML according to WHO diagnostic criteria
(at least 20% blasts in the bone marrow), with FAB classification other than M3 (acute promyelocytic leukemia), documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of more than 6 months duration)
WHO performance status 0-3
Adequate renal (serum creatinine < 2 x the institutional Upper Limit of Normal (ULN)) and liver (total serum bilirubin < 2 x ULN; serum ALT and AST ≤ 3 x ULN) function, unless considered due to organ leukemic involvement
Left Ventricular Ejection Fraction (LVEF) >50%, as determined by echocardiogram
Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection
Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.
Patients aged less than 18 or more than 60 years
Patients already treated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days HU), radiotherapy or more than 7 days corticosteroids
Acute promyelocytic leukaemia
Blast crisis of chronic myeloid leukaemia
AML supervening after other myeloproliferative disease
AML supervening after antecedent myelodysplastic syndromes of more than 6 months duration
Other progressive malignant diseases. However, secondary AML following previously cured malignancies may be included as well as secondary AML following previous exposure to alkylating agents or radiation for other reason
Inadequate renal or liver function (metabolic abnormalities > 3 times the normal upper limit)
Severe heart failure requiring diuretics
Ejection fraction < 50%
WHO performance status = 4
Severe concomitant neurological or psychiatric diseases
Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
All locations for NCT01452646
U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico
Tricase, (le), Italy
Complesso Ospedaliero S. Giovanni Addolorata
Roma, (rm), Italy, 00184
Policlinico di Tor Vergata
Rome, (rm), Italy, 00133
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Az. Ospedaliera S. G. Moscati
Unità Operativa Ematologia 1 - Università degli Studi di Bari
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