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A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor

Phase 2/Phase 3
18 Years
Not Enrolling
Cutaneous T-Cell Lymphoma

Thank you

Trial Information

A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor

Inclusion Criteria

Inclusion criteria:

1. Written informed consent obtained prior to any screening procedures

2. Age greater than or equal to 18 years old

3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome.
Patients with SS who have bone marrow involvement are also eligible. Patients with
transformed CTCL are eligible.

4. Patients must have been treated with an HDAC inhibitor given for the treatment of
CTCL. Patients must have had disease progression on or following treatment with an
HDAC inhibitor. Patients 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. Patients previously treated with an HDAC inhibitor are also eligible if
they experienced intolerance due to adverse events.

Exclusion criteria:

1. Patients with a history of visceral disease including CNS involvement (i.e. stage IVB
CTCL). Note, patients who have SS with bone marrow involvement are eligible.

2. Impaired cardiac function

3. Concomitant use of drugs with a risk of causing torsades de pointes

4. Patients 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

5. Less than 3 months since prior electron beam therapy

6. 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the overall response rate of patients treated with LBH589 by using the modified Severity-Weighted Assessment Tool to assess skin disease and the evaluation of disease in the viscera, lymph nodes, and blood (circulation SS cells)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

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



Roswell Park Cancer Institute Buffalo, New York  14263
Seattle Cancer Care Alliance Seattle, Washington  98109
Medical College of Georgia Augusta, Georgia  30912
The Jones Clinic Germantown, Tennessee  38138
MD Anderson Cancer Center/University of Texas Houston, Texas  77030
NYU Clinical Cancer Center New York, New York  10016
Nebraska Medical Center Omaha, Nebraska  68198
Florida Academic Dermatology Centers Miami, Florida  33136
Wake University Health Sciences Winston-Salem, North Carolina  27157
University of Alabama at Birmingham/ The Kirklin Clinic Birmingham, Alabama  35233
UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology Los Angeles, California  90095
University of Colorado Health Sciences Center/Anschutz Cancer Pavillion Aurora, Colorado  80010
Rush Presbyterian Hospital/St. Luke's Medical Center Chicago, Illinois  60612
St. Louis University Cancer Cennter St. Louis, Missouri  63110
Our Lady of Mercy Medical Center/Comprehensive Cancer Center Bronx, New York  10466
University of Oklahoma-Tulsa Tulsa, Oklahoma  74104
Craig Okada Portland, Oregon  97239
University of Pittsburg Medical Center Pittsburg, Pennsylvania  15213