A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Mitoxantrone; Panobinostat

Criteria

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/exclusion criteria may apply