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A Phase Ib, Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Idarubicin and Cytarabine Induction and High-dose Cytarabine-based Consolidation Therapy in Adult Patients Less Than or Equal to 65 Years Old With Acute Myeloid Leukemia (AML)


Phase 1
18 Years
65 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia (AML)

Thank you

Trial Information

A Phase Ib, Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Idarubicin and Cytarabine Induction and High-dose Cytarabine-based Consolidation Therapy in Adult Patients Less Than or Equal to 65 Years Old With Acute Myeloid Leukemia (AML)


Inclusion Criteria:



- Newly diagnosed adult patients = 65 years old with a cytopathologically confirmed
diagnosis of high-risk AML

- = 20% bone marrow blasts via bone marrow aspiration or biopsy

- The patient has not yet been treated for AML

- 1º or 2º AML patients with high-risk category features

- ECOG PS = 2

- Renal function and liver function limits.

Exclusion Criteria:

- Patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21);
or inv(16) or t(16;16)

- Patient has clinical symptoms suggestive of CNS leukemia and/or CSF findings for CNS
leukemia

- Prior treatment with deacetylase inhibitors (DACi) including, panobinostat

- Impaired cardiac function

- Female patient who is pregnant or breast feeding

- Male patient who is not willing to use a barrier method of contraception

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:

Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589G2101

NCT ID:

NCT01242774

Start Date:

October 2010

Completion Date:

May 2015

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • AML
  • bone marrow
  • abnormal blast cells of myeloid
  • acute leukemia
  • cytogenetic abnormalities
  • HDACi
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Medical University of South Carolina MUSC/HCC (2)Charleston, South Carolina  29425
Dana Farber Cancer Institute Ctr. for Hematologic OncologyBoston, Massachusetts  02115
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospitalColumbus, Ohio  43210
Stanford University Medical Center Stanford UStanford, California  94304
Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3Nashville, Tennessee  37212
MD Anderson Cancer Center/University of Texas Dept of MD Anderson (15)Houston, Texas  77030-4009