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Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
This study is currently recruiting participants.
Verified by Novartis, September 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00425555
  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: 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 Refractory Cutaneous T-Cell Lymphoma

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 118
Study Start Date: December 2006
  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

Contacts
Contact: Novartis 862 778 8300

  Show 50 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: CLBH589B2201
Study First Received: January 22, 2007
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00425555  
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 16, 2009