Clinical Trial: Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: To determine the overall response rate of patients treated with LBH589 by using the modified Severity-Weighted Assessment Tool to assess skin disease and the evaluation of disease in the viscera, lymph nodes, and blood (circulation SS cells) [ Time Frame: Monthly ]

Original Primary Outcome: Response rate assessed by: visceral disease, lymph nodes, blood samples and a modified Severity-Weighted Assessment Tool (mSWAT) score to assess skin disease.

Current Secondary Outcome:

  • To determine the response rate using the Physicians Global Assessment of Clinical Condition(PGA)of patients with resistant CTCL [ Time Frame: Monthly ]
  • To determine the response rate using Modified Severity Weighted Assessment (mSWAT) skin score of patients with resistant CTCL [ Time Frame: Monthly ]
  • Responses in index lesions by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ]
  • Overall response rate of patients with resistant CTCL treated with oral LBH589 by using the modified Physician's Global Assessment (PGA) to assess skin disease and the evaluation of disease in the viscera, lymph nodes and blood (circulating SS cells). [ Time Frame: Monthly ]
  • Duration of response [ Time Frame: Monthly ]


Original Secondary Outcome: Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA) Responses in index lesions assessed by lesion measurements with photographic supporting documentation

Information By: Novartis

Dates:
Date Received: June 21, 2007
Date Started: June 2007
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017