Status:
COMPLETED
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cutaneous T-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00425555
Start Date
January 1 2007
End Date
June 1 2013
Last Update
August 20 2021
Active Locations (42)
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1
University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic
Birmingham, Alabama, United States, 35294-0006
2
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
3
University of California at Los Angeles Dept. of Hematology-Oncology
Los Angeles, California, United States, 90095
4
Florida Academic Dermatology Center
Miami, Florida, United States, 33136