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

Cutaneous T-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00699296
• Other study ID #: CLBH589B1201
• Status: Terminated
• Phase: Phase 2
• First received: June 13, 2008
• Last updated: November 26, 2012
• Start date: May 2008

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Panobinostat (LBH589)
20mg/day p.o. on three times-a- week

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes