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

NCT00699296 | Terminated Phase 2

• 1 other identifier: CLBH589B1201
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Cutaneous T-Cell Lymphoma; Leukemia-Lymphoma, Adult T-Cell

Keywords

LBH589; HDAC inhibitor; cutaneous T-ceII lymphoma; adult T-cell leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: Panobinostat (LBH589)

Interventions

Panobinostat (LBH589) DRUG

20mg/day p.o. on three times-a- week

Also known as: LBH589

1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

University Hospital of Occupational and Environmental Health

Fukuoka, Japan

Location

Imamura Bun-in Hospital

Kagoshima, Japan

Location

Kumamoto University Hospital

Kumamoto, Japan

Location

University of Miyazaki Hospital

Miyazaki, Japan

Location

Nagasaki University Hospital of Medicine and Dentistry

Nagasaki, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

The University of Tokyo Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Leukemia-Lymphoma, Adult T-Cell

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

JP (7)