Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Novartis

Status and phase: Completed; Phase 2

Conditions: Acute Myelogenous Leukemia; Refractory Leukemia

Treatments: Drug: Panobinostat/LBH589

Study type: Interventional

Funder types: Industry

Identifiers

NCT00880269

2008-002983-32 (EudraCT Number)

CLBH589B2213

Details and patient eligibility

About

This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.

Enrollment: 59 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Stratum A

Experimental group

Description:

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.

Treatment:

Drug: Panobinostat/LBH589

Stratum B

Experimental group

Description:

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.

Treatment:

Drug: Panobinostat/LBH589