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Contatti: Davide Rapezzi Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.; Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo. 0171642223
Trattamento: Givinostat
Sindromi MIELOPROLIFERATIVE CRONICHE target: Polycythemia Vera
Criteri inclusione:
1. Patients must be able to provide informed consent and willing to sign an ICF.2. Patients must be 18 years of age or older.3. Patients must have been diagnosed with PV according to the 2016 WHO criteria within 3 years before randomization.4. Patients must have JAK2V617F-positive disease.5. Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at screening6. Patients must be in need of treatment at screening.In addition, patients pre-treated with HU must not have a documented history of resistance or intolerance to HU (see exclusion criterion 1).7. Patients must have normalized HCT (i.e., HCT < 45%) at randomization.8. Patients must have an ECOG performance status ≤ 2 at screening.9. Patients must have a peripheral blood blast count of 0% at screening.10. Female patients must be either postmenopausal, sterilized or, if of childbearing potential and sexually active, effectively practicing a highly effective method of contraception (i.e. failure rate <1%, when used consistently and correctly). Given the increased risk of thrombotic events in PV patients, according to the WHO Medical eligibility criteria for contraceptive use, progesterone-only contraceptives and levonorgestrel are the preferred methods.11. Female patients of childbearing potential must agree to use highly effective contraception during the study and for at least 6 months after the last dose of study treatment if the patient received hydroxyurea. For patients receiving givinostat there is no need to use any highly effective contraception after the last dose of study treatment.12. Male patients must use condoms and ensure that they or their female partner(s) use a highly effective method of contraception as described in inclusion criterion 10 during the study and for at least 1 year after the last dose of study treatment if the patient received hydroxyurea. For patients receiving givinostat there is no need to ensure that they or their female partner(s) use any highly effective contraception after the last dose of study treatment.13. Male patients must not donate sperm during the study and for at least 1 year following the last study drug administration if the patient received hydroxyurea. For patients receiving givinostat there is no need to withheld sperm donation after the last dose of study treatment.14. Patients must be willing and capable to comply with the requirements of the study.
Leggi tutto: AO Santa Croce e Carle di Cuneo - Sindromi mieloprofliferative
Contatti: Carmen Fava Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.; Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo. 011 5082224
Sindromi MIELOPROLIFERATIVE CRONICHE target: leucemia mieloide cronica
Trattamento: Nilotinib + asciminib
1) Diagnosis of CP-CML according to the WHO and no previous history of progression to AP/BP CML.2) First-line treatment with nilotinib for at least 3 calendar years, followed by first TFR attempt.3) Failed first TFR attempt followed by at least 1 year of nilotinib retreatment before enrollment in TFR2 stage.4) MR4 or better (BCR-ABL ≤ 0.01% IS) assessed at screening.5) Patient must meet the following laboratorya. Absolute neutrophil count ≥1.0 x 109/Lb. Platelets ≥75 x 109/Lc. Hemoglobin (Hgb) ≥ 9 g/dLd. Serum creatinine < 1.5 mg/dLe. Total bilirubin ≤ 2 x ULN except for patients with Gilbert’s syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULNf. AST and ALT ≤ 3.0 x ULNg. ALP ≤ 2.5 x ULNh. Serum lipase ≤ 1.5 x ULN.j. Serum levels of potassium, magnesium, total calcium within the normal limits. Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed.
Criteri esclusione:
1) Patients with known atypical transcript.2) CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past).3) Dose reductions/interruptions due to neutropenia or thrombocytopenia in the past 6 months4) History of acute pancreatitis within 1 year prior to study entry or past medical history of chronic pancreatitis5) Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to study entry.
1) Patients with CP-CML, treated with TKI monotherapy or TKI in association with other drugs (such as interferon, BCR-ABL1 peptidic vaccine and others)2) Treatment with TKI discontinued for any reason3) Deep Molecular Response (DMR), defined as MR4, or MR4.5, or MR5 confirmed at least three times before TKI discontinuation In patients who discontinued TKIs before the establishment of molecular standardization, DMR will be defined as a level of BCR-ABL1 transcript undetectable by qPCR or by qualitative PCR, confirmed in at least two controls
Patients who were diagnosed with accelerated or blastic phase CML will be excluded
Leggi tutto: AO Ordine Mauriziano di Torino - Sindromi mieloprofliferative
Contatti: Monia MarchettiQuesto indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.
SCDU Ematologia, AOU SS Antonio e Biagio e Cesare Arrigo - Alessandria
Sindromi MIELOPROLIFERATIVE CRONICHE target: TROMBOCITEMIA ESSENZIALE
Studio di fase 3
Criteri di inclusione: diagnosi di TE secondo WHO 2016 con risposta inadeguata o intolleranza all'idrossiurea e alla terapia citoriduttiva più recente
Contatti: Monia Marchetti Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.
Sindromi MIELOPROLIFERATIVE CRONICHE target: MIELOFIBROSI
Criteri di inclusione: diagnosi di mielofibrosi (primitiva o secondaria a TE/PV) con DIPSS intermedio-2 o alto, refrattarietà a JAK-inibitori, sintomatologia presente e splenomegalia
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