Status:
COMPLETED
Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 chemotherap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01242774
Start Date
October 1 2010
End Date
May 1 2014
Last Update
December 19 2020
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University Medical Center Stanford U
Stanford, California, United States, 94304
2
Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02115
3
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital
Columbus, Ohio, United States, 43210
4
Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)
Charleston, South Carolina, United States, 29425