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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016809-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panobinostat | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat | Drug | Oral administration 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the number of patients who have safety and tolerability events | 1 year | |
| To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center Stanford U | Stanford | California | 94304 | United States | ||
| Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31541945 | Derived | DeAngelo DJ, Walker AR, Schlenk RF, Sierra J, Medeiros BC, Ocio EM, Rollig C, Strickland SA, Thol F, Valera SZ, Dasgupta K, Berkowitz N, Stuart RK. Safety and efficacy of oral panobinostat plus chemotherapy in patients aged 65 years or younger with high-risk acute myeloid leukemia. Leuk Res. 2019 Oct;85:106197. doi: 10.1016/j.leukres.2019.106197. Epub 2019 Aug 1. |
| Label | URL |
|---|---|
| Results for CLBH589G2101 can be found on the Novartis Clinical Trial Results Website | View source |
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|
| To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003) | 1 year |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital | Columbus | Ohio | 43210 | United States |
| Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2) | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3 | Nashville | Tennessee | 37212 | United States |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | Barcelona | 08025 | Spain |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D002869 | Chromosome Aberrations |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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