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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
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose limiting toxicity (DLT)

Outcome Time Frame:

1 cycle (1 cycle = 28 days)

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2116

NCT ID:

NCT01055483

Start Date:

September 2009

Completion Date:

February 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute myeloid leukemia
  • AML
  • relapsed acute myeloid leukemia
  • refractory acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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