Clinical trial NCT00699296: Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
Official title: A Phase II Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cutaneous T-Cell Lymphoma
Leukemia-Lymphoma, Adult T-Cell
Keywords: LBH589
HDAC inhibitor
cutaneous T-ceII lymphoma
adult T-cell leukemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Every Cycle
Secondary outcomes:
measure: 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
timeFrame: 1 cycle
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: University Hospital of Occupational and Environmental Health
city: Kagoshima
country: Japan
facility: Imamura Bun-in Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital of Medicine and Dentistry
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
Study officials:
affiliation: The University of Tokyo Hospital
name: Makoto Sugaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Okayama University
name: Kenji Iwatsuki
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Occupational and Environmental Health
name: Yoshiki Tokura
role: PRINCIPAL_INVESTIGATOR
affiliation: Nagasaki University Hospital of Medicine and Dentistry
name: Kunihiro Tsukasaki
role: PRINCIPAL_INVESTIGATOR
affiliation: Kumamoto University Hospital
name: Hironobu In
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miyazaki Hospital
name: Mitsuru Setoyama
role: PRINCIPAL_INVESTIGATOR
affiliation: Imamura Bun-in Hospital
name: Atae Utsunomiya
role: PRINCIPAL_INVESTIGATOR
References: