Clinical Trial: Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma

Brief Summary: This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma. LBH589 is administered orally once a day for three days per week.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Overall response (CR/PR) rate by using the modified Severity-Weighted Assessment Tool (mSWAT) to assess skin disease and the combined evaluation of disease in the viscera/lymph nodes, peripheral blood and bone marrow [ Time Frame: Every Cycle ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Response rate using mSWAT Response rate using the Physician's Global Assessment of Clinical Condition (PGA) Responses in index lesions by skin lesion measurements and with photographic supporting documentation Overall response(CR/PR) rate by using PG [ Time Frame: 1 cycle ]

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: June 13, 2008
Date Started: May 2008
Date Completion:
Last Updated: November 26, 2012
Last Verified: November 2012