Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

NCT00425555 | Completed Phase 2 Results

• 2 other identifiers: CLBH589B22012006-000880-27
• Study Type: interventional
• Target: 139
• Locations: 12 countries
• Sites: 42

Brief Summary

This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.

Conditions

Cutaneous T-Cell Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)

  Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as: * Complete Response (CR): no evidence of skin disease * Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline * Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score * Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.

  Baseline up to 6 Months of Follow up

Secondary Outcomes (12)

• The Overall Response Rate Using mSWAT Skin Score

  Baseline up to Cycle 12, an average of 12 months

• Time to Response for Responders

  Baseline up to Cycle 12, an average of 12 months

• Duration of Response (DOS)

  Baseline up to Cycle 12, an average of 12 months

• Progression-free Survival (PFS)

  Baseline up to Cycle 12, an average of 12 months

• Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12

  Baseline up to Cycle 12, an average of 12 months

Study Arms (2)

Previously treated with oral bexarotene

EXPERIMENTAL

Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).

Drug: Panobinostat

No prior oral bexarotene treatment

EXPERIMENTAL

Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).

Drug: Panobinostat

Interventions

Panobinostat DRUG

Also known as: LBH589

No prior oral bexarotene treatment; Previously treated with oral bexarotene

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 ≥ 18 years old
• Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible.
• Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
• Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen.
• Patients will be accrued to one of two groups: Patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment.

You may not qualify if:

• Prior treatment with an HDAC inhibitor.
• Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
• Impaired cardiac function
• Concomitant use of drugs with a risk of causing torsades de pointes
• Patients who have received chemotherapy or any investigational drug or undergone major surgery \< 4 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
• Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control, and male patients whose sexual partners are women of childbearing potential not using effective birth control
• Uncontrolled hypertension
• Concomitant use of any anti-cancer therapy or radiation therapy. Low potency topical steroid use is permitted. Topical bexarotene use is prohibited during the trial
• Concomitant use of CYP3A4/5 inhibitors.
• Patients with unresolved diarrhea \> CTCAE grade 1
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
• Other concurrent severe and/or uncontrolled medical conditions
• Patients who would need to receive valproic acid for any reason during the study or ≤ 5 days prior to starting study drug.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (42)

University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic

Birmingham, Alabama, 35294-0006, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

University of California at Los Angeles Dept. of Hematology-Oncology

Los Angeles, California, 90095, United States

Location

Florida Academic Dermatology Center

Miami, Florida, 33136, United States

Location

Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

Atlanta, Georgia, 30322, United States

Location

Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia

Augusta, Georgia, 30912, United States

Location

NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMed

Chicago, Illinois, 60611, United States

Location

Indiana University Dept. of IU Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Boston Medical Center StudyCoordinator:CLBH589B2201

Boston, Massachusetts, 02118, United States

Location

Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3)

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System Michigan HouseClinTrialsOffice

Ann Arbor, Michigan, 48109, United States

Location

Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtr

Winston-Salem, North Carolina, 27157, United States

Location

University Dermatology Consultants

Cincinnati, Ohio, 45219, United States

Location

Oregon Health & Science University Dept. of OHSU Cancer Institute

Portland, Oregon, 97239, United States

Location

University of Pittsburgh Medical Center Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

CABA, Buenos Aires, C1221ADC, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1425AUM, Argentina

Location

Novartis Investigative Site

South Brisbane, Queensland, 4101, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Yvoir, 5530, Belgium

Location

Novartis Investigative Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3T 1E2, Canada

Location

Novartis Investigative Site

Helsinki, 00250 HUS, Finland

Location

Novartis Investigative Site

Lyon, Cedex 02, 69288, France

Location

Novartis Investigative Site

Créteil, 94010, France

Location

Novartis Investigative Site

Paris, 75010, France

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Minden, 32423, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

Novartis Investigative Site

Budapest, H-1085, Hungary

Location

Novartis Investigative Site

Ancona, AN, 60126, Italy

Location

Novartis Investigative Site

Bologna, BO, 40138, Italy

Location

Novartis Investigative Site

Florence, FI, 50129, Italy

Location

Novartis Investigative Site

Torino, TO, 10126, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz Romero P, Grazia Bernengo M, Lebbe C, Assaf C, Squier M, Williams D, Marshood M, Tai F, Prince HM. Panobinostat activity in both bexarotene-exposed and -naive patients with refractory cutaneous T-cell lymphoma: results of a phase II trial. Eur J Cancer. 2013 Jan;49(2):386-94. doi: 10.1016/j.ejca.2012.08.017. Epub 2012 Sep 13.

  PMID: 22981498 RESULT

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

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
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2007
• First Posted: January 23, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 20, 2021
• Results First Posted: August 16, 2021

Record last verified: 2021-08

Locations

AU (2); ES (3); US (16); AR (2); FR (3); DE (3); HU (1); IT (5); CA (2); BE (3); CH (1); FI (1)