Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma
This study is currently recruiting participants.
Verified by Novartis, December 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00490776
  Purpose

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

MedlinePlus related topics: Lymphoma
U.S. FDA Resources
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 diseasein the viscera, lymph nodes, and blood (circulation SS cells) [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the response rate using the Physicians Global Assessment of Clinical Condition(PGA)of patients with resistant CTCL [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • To determine the response rate using Modified Severity Weighted Assessment (mSWAT) skin score of patients with resistant CTCL [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Responses in index lesions by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: June 2007
Arms Assigned Interventions
1: Experimental Drug: LBH589

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Written informed consent obtained prior to any screening procedures
  2. Age greater than or equal to 18 years old
  3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible. Patients with transformed CTCL are eligible.
  4. Patients must have been treated with an HDAC inhibitor given for the treatment of CTCL. Patients must have had disease progression on or following treatment with an HDAC inhibitor. Patients are also eligible if they had an inadequate response to an HDAC inhibitor defined as stable disease as the best response after at least 3 months of therapy. Patients previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.

Exclusion criteria

  1. Patients with a history of visceral disease including CNS involvement (i.e. stage IVB CTCL). Note, patients who have SS with bone marrow involvement are eligible.
  2. Impaired cardiac function
  3. Concomitant use of drugs with a risk of causing torsades de pointes
  4. Patients who have received chemotherapy or any investigational drug or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  5. Less than 3 months since prior electron beam therapy
  6. Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study and 3 months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490776

Contacts
Contact: Novartis 1 800 340 6843

  Show 19 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

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

Keywords provided by Novartis:
Cutaneous T-Cell Lymphoma
adults
Mycosis Fungoides
Sézary Syndrome
CTCL

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009