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NCT01055483 Clinical Trial

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

Acute Myeloid Leukemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01055483
Other study ID # CLBH589B2116
Secondary ID 2008-002986-30
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2009
Est. completion date February 2012

Study information
Verified date February 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• panobinostat/LBH589B

Locations
Country Name City State
France Novartis Investigative Site Paris
France Novartis Investigative Site Paris Cedex 4
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Ulm

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

France,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of dose limiting toxicity (DLT) 1 cycle (1 cycle = 28 days)
Secondary 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
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