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

NCT01055483 | Completed Phase 1

• 2 other identifiers: CLBH589B21162008-002986-30
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 6

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).

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia; AML; relapsed acute myeloid leukemia; refractory acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicity (DLT)

  1 cycle (1 cycle = 28 days)

Secondary Outcomes (1)

• 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

Study Arms (1)

LBH589

EXPERIMENTAL

Drug: panobinostat/LBH589B

Interventions

panobinostat/LBH589B DRUG

LBH589

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Paris, 75181, France

Location

Novartis Investigative Site

Paris, 75475, France

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Related Links

• Results for LBH589B2116 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 25, 2010
• Study Start: September 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 19, 2020

Record last verified: 2013-02

Locations

DE (4); FR (2)