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


Phase 2
20 Years
N/A
Not Enrolling
Both
Cutaneous T-Cell Lymphoma, Leukemia-Lymphoma, Adult T-Cell

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome 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

Outcome Time Frame:

Every Cycle

Safety Issue:

No

Principal Investigator

Makoto Sugaya

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Tokyo Hospital

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CLBH589B1201

NCT ID:

NCT00699296

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Cutaneous T-cell Lymphoma
  • Leukemia-Lymphoma, Adult T-Cell
  • LBH589
  • HDAC inhibitor
  • cutaneous T-ceII lymphoma
  • adult T-cell leukemia
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

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