Trial Search Results

Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)

This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the combination in this regimen.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Intervention(s):

  • Drug: Panobinostat

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting