acute myeloid leukemia and high risk myelodysplastic syndrome
Conditions
Interventions
Treatment with LGH447 with or without midostaurin.
Sponsors
Novartis Pharma BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients *18 years.with refractory/relapsed AML (see protocol page 44 for details). 2. Patients with active CNS disease are eligible and may be treated concurrently with intrathecal (or intra Ommaya) chemotherapy. 3. Patients are eligible as long as previous and concomitant medications are in line with the with the list of approved concomitant medications (see protocol appendix 5 for details). 4. ECOG performance status 0-2.
Exclusion criteria
Exclusion criteria: 1. Systemic antineoplastic therapy or any experimental therapy within 7 days or 5 half-lives, whichever is longer, before the first dose of LGH447 with or without midostaurin (see protocol page 45 for further details). 2. Radiotherapy with a wide field of radiation within 28 days or radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of LGH447 with or without midostaurin. 3. CNS irradiation for meningeal leukemia, except if radiotherapy occurred > 3 months previously. 4. Ongoing systemic therapy with corticosteroids greater than 10 mg of prednisone or its equivalent per day. 5. Uncontrolled cardiovascular condition within the past 6 months. 6. Active infection requiring systemic therapy or other severe infection with 2 weeks before the first dose of LGH447. 7. Currently receiving hydroxyurea to control peripheral blood leukemic blasts that cannot be discontinued for at least 48 hours prior to obtaining PD biomarkers at screening/baseline and during the study. 8. Other prohibited medications (see protocol page 27 for details). 9. Pregnancy, lactation. 10. Inadequate contraception for women of childbearing potential (see protocol page 46 for details). 11 Sexually active males must use a condom during intercourse while taking the drug and for 96 days after stopping treatment and should not father a child in this period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of dose limiting toxicities during the first cycle of LGH447 with or without midostaurin treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response, adverse events, dose interruptions, dose reductions, and dose intensity. | — |
Countries
Netherlands
Outcome results
None listed