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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cutaneous T-Cell Lymphoma

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Trial Information

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

Inclusion Criteria


Inclusion criteria:

1. Written informed consent obtained prior to any screening procedures

2. Age ≥ 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.

4. 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, chemotherapy such as methotrexate, and interferon. Topical
steroids alone are not considered as a treatment regimen.

5. Patients must have had disease progression on or following their most recent
treatment regimen or an inadequate response to their most recent treatment regimen.

6. 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.

Exclusion criteria:

1. Prior treatment with an HDAC inhibitor.

2. Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL).
Note; Patients with SS who have bone marrow involvement are eligible.

3. Impaired cardiac function

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

5. 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

6. Less than 3 months since prior electron beam therapy

7. 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
Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate assessed by: visceral disease, lymph nodes, blood,samples and a modified Severity-Weighted Assessment Tool (mSWAT) score to assess skin disease

Outcome Time Frame:

Monthly

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2201

NCT ID:

NCT00425555

Start Date:

January 2007

Completion Date:

June 2013

Related Keywords:

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

Name

Location

City of Hope National Medical CenterLos Angeles, California  91010
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)Atlanta, Georgia  30322
University Dermatology ConsultantsCincinnati, Ohio  45219
Florida Academic Dermatology CenterMiami, Florida  33136
University of Alabama at Birmingham/ Kirklin Clinic Kirklin ClinicBirmingham, Alabama  35294-0006
University of California at Los Angeles Dept. of Hematology-OncologyLos Angeles, California  90095
Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgiaAugusta, Georgia  30912
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMedChicago, Illinois  60611
Indiana University Dept. of IU Cancer CenterIndianapolis, Indiana  46202
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3)Boston, Massachusetts  02115
Boston Medical Center StudyCoordinator:CLBH589B2201Boston, Massachusetts  02118
University of Michigan Health System Michigan HouseClinTrialsOfficeAnn Arbor, Michigan  48109
Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtrWinston-Salem, North Carolina  27157
Oregon Health & Science University Dept. of OHSU Cancer InstitutePortland, Oregon  97239
University of Pittsburgh Medical Center Department of DermatologyPittsburgh, Pennsylvania  15213
MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201Houston, Texas  77030