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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00425555 |
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
Condition | Intervention | Phase |
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Cutaneous T-Cell Lymphoma |
Drug: Panobinostat |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma |
Estimated Enrollment: | 118 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Previously treated with oral bexarotene: Experimental | Drug: Panobinostat |
No prior oral bexarotene treatmemt: Experimental | Drug: Panobinostat |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CLBH589B2201 |
Study First Received: | January 22, 2007 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00425555 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cutaneous T-Cell Lymphoma, adults Mycosis Fungoides Sézary Syndrome CTCL |
Lymphatic Diseases Mycoses Immunoproliferative Disorders Cutaneous T-cell Lymphoma Lymphoma, T-Cell Sezary Syndrome |
Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Lymphoma, T-Cell |
Sezary Syndrome Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |