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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00425555
First received: January 22, 2007
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  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: Single Group 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:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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 ]

Estimated Enrollment: 118
Study Start Date: December 2006
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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

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

Additional Information:
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.  This link exits the ClinicalTrials.gov site

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
Study First Received: January 22, 2007
Last Updated: May 10, 2013
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 May 16, 2013