Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)

NCT00490776 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CLBH589B2212
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 18

Brief Summary

This study evaluated the safety and efficacy of LBH589B in adult participants with refractory/resistant Cutaneous T-Cell Lymphoma and prior Histone Deacetylase (HDAC) inhibitor therapy.

Conditions

Cutaneous T-Cell Lymphoma

Keywords

Cutaneous T-Cell Lymphoma; adults; Mycosis Fungoides; Sézary Syndrome; CTCL

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) in Participants With Resistant Cutaneous T-Cell Lymphoma (CTCL) Treated With Oral Panobinostat by Using the Modified Severity-Weighted Assessment Tool (mSWAT)

  ORR was defined as the percentage of participants with best overall response (OR) of complete response (CR) or partial response (PR) based on mSWAT score, (OR = CR + PR). mSWAT score represents the product of the percentage total body surface area (%TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: modified SWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score.

  From first dose of study drug up to disease progression or death, (up to approximately 2 years)

Secondary Outcomes (7)

• Response Rate of Participants With Refractory CTCL Using the Physician's Global Assessment of Clinical Condition (PGA)

  From first dose of study drug up to disease progression or death, (up to approximately 2 years)

• Response Rate in Participants With Refractory CTCL Using Modified Skin Score

  From first dose of study drug up to disease progression or death, (up to approximately 2 years)

• Responses in Index Lesions in Participants With Refractory CTCL by Lesion Measurements With Photographic Supporting Documentation

  From first dose of study drug up to disease progression or death (up to approximately 2 years)

• ORR of Participants With Resistant CTCL Treated With Oral Panobinostat by Using the Modified PGA to Assess Skin Disease and the Evaluation of Disease in the Viscera, Lymph Nodes and Blood (Circulating Sézary Syndrome Cells)

  From first dose of study drug up to disease progression or death, (up to approximately 2 years)

• Duration of Response (DOR)

  From first dose of study drug up to disease progression or death, (up to approximately 2 years)

Study Arms (1)

Panobinostat 20 mg

EXPERIMENTAL

Participants received panobinostat, 20 milligrams (mg), capsules, orally, thrice weekly on alternate Days 1, 3, and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression, and/or physician's discretion to discontinue the treatment.

Drug: Panobinostat

Interventions

Panobinostat DRUG

Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly.

Also known as: LBH589

Panobinostat 20 mg

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained prior to any screening procedures
• Age greater than or equal to 18 years old
• Participants with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome (SS). Participants with SS who have bone marrow involvement are also eligible. Participants with transformed CTCL are eligible
• Participants must have been treated with an HDAC inhibitor given for the treatment of CTCL. Participants must have had disease progression on or following treatment with an HDAC inhibitor. Participants are also eligible if they had an inadequate response to an HDAC inhibitor defined as stable disease as the best response after at least 3 months of therapy. Participants previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.
• Baseline multiple-gated acquisition scan (MUGA) or echocardiogram must have demonstrated left ventricular ejection fraction (LVEF) ≥ the lower limit of the institutional normal
• ECOG performance status ≤ 2

You may not qualify if:

• Participants with a history of visceral disease including central nervous system (CNS) involvement (i.e. stage IVB CTCL). Note, participants who have SS with bone marrow involvement are eligible
• Impaired cardiac function
• Concomitant use of drugs with a risk of causing torsades de pointes
• Participants who have received chemotherapy or any investigational drug or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• Less than 3 months since prior electron beam therapy
• Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study and 3 months after the end of treatment.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

University of Alabama at Birmingham/ The Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology

Los Angeles, California, 90095, United States

Location

University of Colorado Health Sciences Center/Anschutz Cancer Pavillion

Aurora, Colorado, 80010, United States

Location

Florida Academic Dermatology Centers

Miami, Florida, 33136, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Rush Presbyterian Hospital/St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

St. Louis University Cancer Cennter

St Louis, Missouri, 63110, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

Our Lady of Mercy Medical Center/Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

Wake University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Oklahoma-Tulsa

Tulsa, Oklahoma, 74104, United States

Location

Craig Okada

Portland, Oregon, 97239, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

The Jones Clinic

Germantown, Tennessee, 38138, United States

Location

MD Anderson Cancer Center/University of Texas

Houston, Texas, 77030, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-102, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated early due to low accrual, no formal efficacy analyses were conducted for this study.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 21, 2007
• First Posted: June 25, 2007
• Study Start: July 5, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 22, 2009
• Last Updated: August 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-08

Locations

US (18)