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
18 Years
65 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia (AML)
Both
Acute Myeloid Leukemia (AML)
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 Oncology | Boston, Massachusetts 02115 |
| Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital | Columbus, Ohio 43210 |
| Stanford University Medical Center Stanford U | Stanford, California 94304 |
| Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3 | Nashville, Tennessee 37212 |
| MD Anderson Cancer Center/University of Texas Dept of MD Anderson (15) | Houston, Texas 77030-4009 |
