Acute Myeloid Leukemia
Conditions
Keywords
Acute myeloid leukemia, AML, relapsed acute myeloid leukemia, refractory acute myeloid leukemia
Brief summary
The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).
Interventions
DRUGpanobinostat/LBH589B
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia. * First relapsed AML * Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR. * Age more than 18 years * ECOG performance status \< 2
Exclusion criteria
* Prior treatment with deacetylase inhibitor * Concurrent therapy with any other investigational agent * Patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study. * Clinical symptoms suggesting CNS leukemia * LVEF below 45% Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicity (DLT) | 1 cycle (1 cycle = 28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0 | During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment |
Countries
France, Germany
Outcome results
None listed