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Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
Not Recruiting
Trial ID: NCT01242774
Purpose
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.
Official Title
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)
Stanford Investigator(s)
Rondeep Brar
Clinical Associate Professor, Medicine - Hematology
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Jason Gotlib
Professor of Medicine (Hematology)
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
Intervention(s):
drug: panobinostat
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061