newly diagnosed FLT3 mutated acute myeloid leukemia MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: midostaurin (INN)
Product Code: PKC412
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: midostaurin
CAS Number: 120685-11-2
Current Sponsor code: PKC412
Other descriptive name: MI
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients eligible for inclusion in this study have to meet all of the following criteria: 1. Written informed consent must be obtained prior to any screening procedures. 2. Patients must be 18 years of age or older at the time of signing informed consent. 3. Patients must have a documented unequivocal diagnosis of AML according to WHO 2008 classification. A bone marrow or blood blast count of =20% is required, except for AML with t(15;17), t(8;21), inv(16) or t(16;16)) where blast count may be =65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: Patients eligible for this study must not meet any of the following criteria: 1. Prior therapy for AML with the following exceptions: a. emergency leukapheresis b. emergency treatment for hyperleukocytosis with hydroxyurea for = 7 days c. cranial RT for CNS leukocytosis (one dose only) d. growth factor/cytokine support 2. Patients with Left Ventricular Ejection Fraction (LVEF) less than 45% (by echocardiogram or MUGA) or symptomatic congestive heart failure (Class III or IV) according to New York Heart Association (NYHA) classification 3. Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolved to 470 msec on screening ECG (Fridericia's formula). 6. History of hypersensitivity to any drugs or metabolites of similar chemical classes as the study treatment. 7. Participation in a prior investigational interventional (drug) study with administration of the investigational product within 30 days or 5 half-lives of the investigational product, whichever is longer. 8. Pregnancy statements and contraception requirements: Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 4 months after stopping medication. Highly effective contraception methods include: • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment • Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject. • Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system , or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should also add a barrier method of contraception, particularly as it is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives. Sexually-active males unless they use a condom during intercourse with females of reproductive potential or pregnant women and for at least 4 months after stopping treatment to avoid conception or embryo-fetal harm. 9. Patients enrolled in this study are not permitted to participate in additional parallel study drug or device studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To further assess the safety of midostaurin in induction, consolidation and maintenance therapy, including, the “7+3” regimen, daunorubicin (60-90mg/m2/day), the substitution of daunorubicin by idarubicin and cytarabine (100-200 mg/m2/day) and also allowing the “5+2” reduced dose regimen.;Secondary Objective: To assess the clinical efficacy of midostaurin in combination with chemotherapy regimens in induction and consolidation and the clinical efficacy of midostaurin maintenance phase (measured by CR/CRi rate).;Primary end point(s): Proportion of patients with AEs, Grade 3&4 AEs, SAEs, AEs leading to discontinuation, and deaths. ;Timepoint(s) of evaluation of this end point: at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with CR/CRi as per local assessment;Timepoint(s) of evaluation of this end point: at end of study | — |
Countries
Bulgaria, Croatia, Czech Republic, Estonia, Finland, France, Greece, Hungary, Italy, Lithuania, Slovakia, Spain, Sweden
Contacts
Public ContactMedical Information Service
Novartis Finland Oy
Outcome results
None listed