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

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Adult patients with stages IB to IVA mycosis fungoides (MF) or Sézary syndrome (SS). Patients with any history of visceral involvement of their CTCL will not be eligible for this study. Patients with Sézary syndrome and bone marrow involvement are eligible. All patients must have received at least two prior systemic treatment regimens for their MF or SS.; MedDRA version: 14.1Level: LLTClassification code 10011679Term: Cutaneous T-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2006-000880-27-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-13
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 139

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. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. NOTE: patients with any history of visceral involvement due to CTCL (i.e. stage IVB disease) are not eligible for this study.
4. Patients must have received at least two prior systemic therapy regimens. 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. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
? Disease progression on following treatment oral bexarotene, OR
? An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
? Intolerance of oral bexarotene defined as patients who discontinued oral bexarotene treatment due to adverse events.
Group 2: Patients who have not had prior oral bexarotene treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 89
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Prior treatment with an HDAC inhibitor for CTCL.
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. Patients who have been previously treated with LBH589.
4. Impaired cardiac function
5. Concomitant use of drugs with a risk of causing torsades de pointes
6. 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
7. Less than 3 months since prior electron beam therapy
8. 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. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at baseline.
9. Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment. One of these methods of contraception must be a condom.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified