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OpenTrials
Completed

NCT Number: NCT01055483

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

panobinostat/LBH589B

Drug

Primary outcomes

  1. Incidence of dose limiting toxicity (DLT)

    Time frame: 1 cycle (1 cycle = 28 days)

Secondary outcomes

  1. Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0

    Time frame: During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2010
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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