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

Brief Summary: This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current 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 [ 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:

  • Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA) [ Time Frame: Monthly ]
  • Responses in index lesions assessed by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ]
  • Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes [ Time Frame: Monthly ]
  • Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation [ Time Frame: Every Visit ]
  • Pharmacokinetic (PK) profile of LBH589 [ Time Frame: 1st month of treatment ]


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
  • Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes
  • Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation
  • Pharmacokinetic (PK) profile of LBH589


Information By: Novartis

Dates:
Date Received: January 22, 2007
Date Started: January 2007
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016