Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
Refractory Leukemia, Acute Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Refractory Leukemia focused on measuring Acute myeloid leukemia, AML, relapsed acute myeloid leukemia, refractory AML, refractory de novo AML, refractory secondary AML, secondary AML, AML following myelodysplastic syndrome (MDS), AML following antecedent hematological disorder (AHD), AML resistant to therapy
Eligibility Criteria
Inclusion Criteria:
- Written informed consent prior to study-specific screening procedures
- Life expectancy of ≥ 60 days
- Eastern Cooperative Group (ECOG) performance status ≤ 2
- Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
- Negative serum pregnancy test (within 7 days of first dose)
- Negative urine pregnancy test immediately prior to first dose
Exclusion Criteria:
- Known HIV
- Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
- Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
- Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
- Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment
- Patient unable to swallow capsules
- Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat
Other Protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)
- Nebraska Methodist Hospital Nebraska Methodist Hospital(2)
- North Shore University Hospital North Shore Univ
- Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)
- Oregon Health Sciences University Dept. of OHSU (2)
- University of Texas Southwestern Medical Center Dept of Simmons Cancer Center
- University of Texas/MD Anderson Cancer Center Dept of MD Anderson (14)
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Stratum A
Stratum B
patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.