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Study of Oral LBH589 in Patients With Cutaneous T-Cell Lymphoma and Adult T-Cell Leukemia/Lymphoma
This study is currently recruiting participants.
Verified by Novartis, November 2008
Sponsors and Collaborators: Novartis
no collaborators
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00699296
  Purpose

This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma. LBH589 is administered orally once a day for three days per week.


Condition Intervention Phase
Cutaneous T-Cell Lymphoma
Leukemia-Lymphoma, Adult T-Cell
Drug: Panobinostat (LBH589)
Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Oral LBH589 in Patients With Cutaneous T-Cell Lymphoma and Adult T-Cell Leukemia/Lymphoma

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall response (CR/PR) rate by using the modified Severity-Weighted Assessment Tool (mSWAT) to assess skin disease and the combined evaluation of disease in the viscera/lymph nodes, peripheral blood and bone marrow [ Time Frame: Every Cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate using mSWAT Response rate using the Physician's Global Assessment of Clinical Condition (PGA) Responses in index lesions by skin lesion measurements and with photographic supporting documentation Overall response(CR/PR) rate by using PG [ Time Frame: 1 cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: May 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Panobinostat (LBH589)
20mg/day p.o. on three times-a- week

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • CTCL: Biopsy-confirmed MF or SS stages IB-IVA2.
  • Patients who have SS with bone marrow involvement are also eligible.
  • Patients with transformed CTCL are eligible.
  • ATL: Patient with cytologically or histopathologically confirmed lymphoma.
  • Lymphoma should be identified as tumors derived peripheral T-cells by cell surface marker.
  • ATL: Patients with positivity for anti-HTLV-1 antibody
  • Patients must have received at least two systemic therapy regimens.
  • Patients must have had disease progression on or following their most recent treatment regimen.
  • Age ≥ 20 years
  • ECOG Performance Status of ≤ 2
  • Written informed consent obtained prior to any study specific screening procedures

Exclusion criteria

  • Patients with a history of primary CNS tumors
  • Any history or presence of brain metastases
  • Patients with any peripheral neuropathy ≥ CTCAE grade 2
  • Patients with unresolved diarrhea > CTCAE grade 1
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
  • Patients with concurrent severe and/or uncontrolled liver or renal disease
  • Patients using sodium valproate ≤5 days prior to starting study drug
  • Patients with an active bleeding diathesis or on any treatment with therapeutic doses of sodium warfarin or other antivitamin K drugs
  • Patients who have received any investigational drug or chemotherapy or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who have received biologic therapy, target therapy (e.g. denileukin diftitix ), vaccine, systemic steroids or immunotherapy ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
  • Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699296

Contacts
Contact: Novartis Pharma KK +81-3-3498-6393

Locations
Japan
The University of Tokyo Hospital Recruiting
Tokyo, Japan
Contact     +81-3-3498-6393        
Okayama University Hospital Recruiting
Okayama, Japan
Contact     +81-3-3498-6393        
University Hospital of Occupational and Environmental Health Recruiting
Fukuoka, Japan
Contact     +81-3-3498-6393        
Imamura Bun-in Hospital Recruiting
Kagoshima, Japan
Contact     +81-3-3498-6393        
Kumamoto University Hospital Recruiting
Kumamoto, Japan
Contact     +81-3-3498-6393        
University of Miyazaki Hospital Recruiting
Miyazaki, Japan
Contact     +81-3-3498-6393        
Nagasaki University Hospital of Medicine and Dentistry Recruiting
Nagasaki, Japan
Contact     +81-3-3498-6393        
Sponsors and Collaborators
Novartis
no collaborators
Investigators
Principal Investigator: Makoto Sugaya The University of Tokyo Hospital
Principal Investigator: Kenji Iwatsuki Okayama University
Principal Investigator: Yoshiki Tokura University Hospital of Occupational and Environmental Health
Principal Investigator: Kunihiro Tsukasaki Nagasaki University Hospital of Medicine and Dentistry
Principal Investigator: Hironobu In Kumamoto University Hospital
Principal Investigator: Mitsuru Setoyama University of Miyazaki Hospital
Principal Investigator: Atae Utsunomiya Imamura Bun-in Hospital
  More Information

Responsible Party: Novartis Pharma K.K.: Japan ( External Affairs )
Study ID Numbers: CLBH589B1201
Study First Received: June 13, 2008
Last Updated: November 12, 2008
ClinicalTrials.gov Identifier: NCT00699296  
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
LBH589
HDAC inhibitor
cutaneous T-ceII lymphoma
adult T-cell leukemia

Study placed in the following topic categories:
Sezary syndrome
Leukemia, Lymphoid
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Leukemia-Lymphoma, Adult T-Cell
Sezary Syndrome
Mycosis Fungoides
Leukemia
Mycoses
Lymphatic Diseases
Lymphoma, T-Cell
Leukemia, T-Cell
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