Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
NCT ID: NCT00699296
Last Updated: 2012-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Panobinostat (LBH589)
20mg/day p.o. on three times-a- week
Interventions
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Panobinostat (LBH589)
20mg/day p.o. on three times-a- week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Makoto Sugaya
Role: PRINCIPAL_INVESTIGATOR
The University of Tokyo Hospital
Kenji Iwatsuki
Role: PRINCIPAL_INVESTIGATOR
Okayama University
Yoshiki Tokura
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Occupational and Environmental Health
Kunihiro Tsukasaki
Role: PRINCIPAL_INVESTIGATOR
Nagasaki University Hospital of Medicine and Dentistry
Hironobu In
Role: PRINCIPAL_INVESTIGATOR
Kumamoto University Hospital
Mitsuru Setoyama
Role: PRINCIPAL_INVESTIGATOR
University of Miyazaki Hospital
Atae Utsunomiya
Role: PRINCIPAL_INVESTIGATOR
Imamura Bun-in Hospital
Locations
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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
Countries
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Other Identifiers
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CLBH589B1201
Identifier Type: -
Identifier Source: org_study_id