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

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

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.

Study Overview

• Status: Terminated
• Conditions: Leukemia-Lymphoma, Adult T-Cell; Cutaneous T-Cell Lymphoma
• Intervention / Treatment: Drug: Panobinostat (LBH589)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • University Hospital of Occupational and Environmental Health
  • Kagoshima, Japan
    • Imamura Bun-in Hospital
  • Kumamoto, Japan
    • Kumamoto University Hospital
  • Miyazaki, Japan
    • University of Miyazaki Hospital
  • Nagasaki, Japan
    • Nagasaki University Hospital of Medicine and Dentistry
  • Okayama, Japan
    • Okayama University Hospital
  • Tokyo, Japan
    • The University of Tokyo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Panobinostat (LBH589); 20mg/day p.o. on three times-a- week; Other Names: LBH589

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Every Cycle

Secondary Outcome Measures

Outcome Measure	Time Frame
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	1 cycle

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (Estimate): June 17, 2008

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: HDAC inhibitor; LBH589; cutaneous T-ceII lymphoma; adult T-cell leukemia
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Lymphoma; Leukemia; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Histone Deacetylase Inhibitors; Panobinostat
• Other Study ID Numbers: CLBH589B1201