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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00490776 |
This study will evaluate the safety and efficacy of LBH589B in adult patients with refractory/resistant Cutaneous T-Cell Lymphoma and prior HDAC inhibitor therapy.
Condition | Intervention | Phase |
---|---|---|
Cutaneous T-Cell Lymphoma |
Drug: LBH589 |
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 Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor |
Estimated Enrollment: | 41 |
Study Start Date: | June 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: LBH589 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis | 1 800 340 6843 |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CLBH589B2212 |
Study First Received: | June 21, 2007 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00490776 |
Health Authority: | United States: Food and Drug Administration |
Cutaneous T-Cell Lymphoma adults Mycosis Fungoides Sézary Syndrome CTCL |
Lymphatic Diseases Mycoses Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Lymphoma, T-Cell |
Sezary Syndrome Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |