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

Completed · Phase 2

Conditions studied: Cutaneous T-Cell Lymphoma

In brief

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

Key facts

Study ID

NCT00425555

Run by

Novartis Pharmaceuticals

People needed

139

Starts

2007-01-01

Expected to finish

2013-06-01

Last updated by the study team

2021-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of California at Los Angeles Dept. of Hematology-Oncology — Los Angeles, California, United States
• Florida Academic Dermatology Center — Miami, Florida, United States
• Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) — Atlanta, Georgia, United States
• Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia — Augusta, Georgia, United States
• NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMed — Chicago, Illinois, United States
• Indiana University Dept. of IU Cancer Center — Indianapolis, Indiana, United States
• Boston Medical Center StudyCoordinator:CLBH589B2201 — Boston, Massachusetts, United States
• Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3) — Boston, Massachusetts, United States
• University of Michigan Health System Michigan HouseClinTrialsOffice — Ann Arbor, Michigan, United States
• Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtr — Winston-Salem, North Carolina, United States
• University Dermatology Consultants — Cincinnati, Ohio, United States
• Oregon Health & Science University Dept. of OHSU Cancer Institute — Portland, Oregon, United States
• University of Pittsburgh Medical Center Department of Dermatology — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201 — Houston, Texas, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — South Brisbane, Queensland, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Yvoir, Belgium
• Novartis Investigative Site — Ottawa, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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