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

Stopped early · Phase 2

Conditions studied: Cutaneous T-Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00490776

Run by

Novartis Pharmaceuticals

People needed

9

Starts

2007-07-05

Expected to finish

2009-09-22

Last updated by the study team

2021-08-18

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

Where it is running

• University of Alabama at Birmingham/ The Kirklin Clinic — Birmingham, Alabama, United States
• UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology — Los Angeles, California, United States
• University of Colorado Health Sciences Center/Anschutz Cancer Pavillion — Aurora, Colorado, United States
• Florida Academic Dermatology Centers — Miami, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Rush Presbyterian Hospital/St. Luke's Medical Center — Chicago, Illinois, United States
• St. Louis University Cancer Cennter — St Louis, Missouri, United States
• Nebraska Medical Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• NYU Clinical Cancer Center — New York, New York, United States
• Our Lady of Mercy Medical Center/Comprehensive Cancer Center — The Bronx, New York, United States
• Wake University Health Sciences — Winston-Salem, North Carolina, United States
• University of Oklahoma-Tulsa — Tulsa, Oklahoma, United States
• Craig Okada — Portland, Oregon, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• The Jones Clinic — Germantown, Tennessee, United States
• MD Anderson Cancer Center/University of Texas — Houston, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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