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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Panobinostat (LBH589)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-Cell Lymphoma focused on measuring LBH589, HDAC inhibitor, cutaneous T-ceII lymphoma, adult T-cell leukemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2008
Last Updated
November 26, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00699296
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-Cell Lymphoma, Leukemia-Lymphoma, Adult T-Cell
Keywords
LBH589, HDAC inhibitor, cutaneous T-ceII lymphoma, adult T-cell leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Panobinostat (LBH589)
Other Intervention Name(s)
LBH589
Intervention Description
20mg/day p.o. on three times-a- week
Primary Outcome Measure Information:
Title
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
Time Frame
Every Cycle
Secondary Outcome Measure Information:
Title
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
Time Frame
1 cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Sugaya
Organizational Affiliation
The University of Tokyo Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenji Iwatsuki
Organizational Affiliation
Okayama University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoshiki Tokura
Organizational Affiliation
University Hospital of Occupational and Environmental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kunihiro Tsukasaki
Organizational Affiliation
Nagasaki University Hospital of Medicine and Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hironobu In
Organizational Affiliation
Kumamoto University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitsuru Setoyama
Organizational Affiliation
University of Miyazaki Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atae Utsunomiya
Organizational Affiliation
Imamura Bun-in Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Occupational and Environmental Health
City
Fukuoka
Country
Japan
Facility Name
Imamura Bun-in Hospital
City
Kagoshima
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki
Country
Japan
Facility Name
Nagasaki University Hospital of Medicine and Dentistry
City
Nagasaki
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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