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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00425555
First received: January 22, 2007
Last updated: April 2, 2014
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Cutaneous T-Cell Lymphoma
Drug: Panobinostat
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA) [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Responses in index lesions assessed by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation [ Time Frame: Every Visit ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) profile of LBH589 [ Time Frame: 1st month of treatment ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: January 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Previously treated with oral bexarotene Drug: Panobinostat
Other Name: LBH589
Experimental: No prior oral bexarotene treatmemt Drug: Panobinostat
Other Name: 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 ≥ 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.
  4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
  5. Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen.
  6. Patients will be accrued to one of two groups: Patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment.

Exclusion criteria:

  1. Prior treatment with an HDAC inhibitor.
  2. Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
  3. Impaired cardiac function
  4. Concomitant use of drugs with a risk of causing torsades de pointes
  5. Patients who have received chemotherapy or any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  6. Less than 3 months since prior electron beam therapy
  7. Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control, and male patients whose sexual partners are women of childbearing potential not using effective birth control Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425555

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic
Birmingham, Alabama, United States, 35294-0006
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
University of California at Los Angeles Dept. of Hematology-Oncology
Los Angeles, California, United States, 90095
United States, Florida
Florida Academic Dermatology Center
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
Atlanta, Georgia, United States, 30322
Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia
Augusta, Georgia, United States, 30912
United States, Illinois
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMed
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Dept. of IU Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3)
Boston, Massachusetts, United States, 02115
Boston Medical Center StudyCoordinator:CLBH589B2201
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Health System Michigan HouseClinTrialsOffice
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtr
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Dermatology Consultants
Cincinnati, Ohio, United States, 45219
United States, Oregon
Oregon Health & Science University Dept. of OHSU Cancer Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh Medical Center Department of Dermatology
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201
Houston, Texas, United States, 77030
Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1221ADC
Novartis Investigative Site
Buenos Aires, Argentina, C1425AUM
Australia, Queensland
Novartis Investigative Site
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia, 3002
Belgium
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Godinne, Belgium, 5530
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Finland
Novartis Investigative Site
Helsinki, Finland, 00029 HUS
France
Novartis Investigative Site
Lyon, Cedex 02, France, 69288
Novartis Investigative Site
Creteil, France, 94010
Novartis Investigative Site
Paris, France, 75010
Germany
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Frankfurt/M, Germany, 60590
Novartis Investigative Site
Minden, Germany, 32423
Novartis Investigative Site
Würzburg, Germany, 97080
Hungary
Novartis Investigative Site
Budapest, Hungary, H-1085
Novartis Investigative Site
Szeged, Hungary, H-6720
Italy
Novartis Investigative Site
Ancona, AN, Italy, 60126
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Firenze, FI, Italy, 50129
Novartis Investigative Site
Torino, TO, Italy, 10126
Novartis Investigative Site
Napoli, Italy, 80131
Spain
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08036
Novartis Investigative Site
Madrid, Spain, 28006
Novartis Investigative Site
Madrid, Spain, 28041
Switzerland
Novartis Investigative Site
Zürich, Switzerland, 8091
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00425555     History of Changes
Other Study ID Numbers: CLBH589B2201, 2006-000880-27
Study First Received: January 22, 2007
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 15, 2014