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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: panobinostat/LBH589B

• Registration Number: NCT01055483
• Lead Sponsor: Novartis Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-25
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-02
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LBH589	panobinostat/LBH589B	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose limiting toxicity (DLT)	1 cycle (1 cycle = 28 days)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Ulm, Germany