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Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00699296
First received: June 13, 2008
Last updated: November 26, 2012
Last verified: November 2012
  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 2

Study Type: Interventional
Study Design: 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 Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma

Resource links provided by NLM:


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 ]

Enrollment: 4
Study Start Date: May 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Panobinostat (LBH589)
20mg/day p.o. on three times-a- week
Other Name: LBH589

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699296

Locations
Japan
University Hospital of Occupational and Environmental Health
Fukuoka, Japan
Imamura Bun-in Hospital
Kagoshima, Japan
Kumamoto University Hospital
Kumamoto, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Nagasaki University Hospital of Medicine and Dentistry
Nagasaki, Japan
Okayama University Hospital
Okayama, Japan
The University of Tokyo Hospital
Tokyo, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00699296     History of Changes
Other Study ID Numbers: CLBH589B1201
Study First Received: June 13, 2008
Last Updated: November 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Immune System Diseases
Immunoproliferative Disorders
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Panobinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014