EUCTR2006-000880-27-FI进行中（未招募）不适用
A Phase II Study Of Oral LBH589 In Adult Patients With Refractory Cutaneous T-Cell Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. 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:
- •1. Disease progression on following treatment oral bexarotene, OR
- •2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
- •3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
- •Group 2: Patients who have not had prior oral bexarotene treatment.
- •7. Patients must have specific laboratory values (see protocol)
- •8. Baseline MUGA or ECHO must demonstrate LVEF = the lower limit of the institutional normal
- •9. ECOG Performance Status = 2
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 (details see protocol)
- •4. Concomitant use of drugs with a risk of causing torsades des 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. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to administration of oral LBH589
- •8. Male patients whose sexual partners are WOCBP not using effective birth control
研究者
相似试验
进行中（未招募）
不适用
A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of TherapyPatients with relapsed multiple myeloma who have received at least two prior lines of therapy and whose disease is refractory to the most recent line of therapy. Prior therapy must have included bortezomib or lenalidomide.MedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2006-004087-31-NLovartis Pharma Services AG144
进行中（未招募）
不适用
A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of Therapy - NDMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomamultiple myelomaEUCTR2006-004087-31-ITOVARTIS FARMA144
进行中（未招募）
不适用
A Phase II Study Of Oral LBH589 In Adult Patients With Refractory Cutaneous T-Cell LymphomaEUCTR2006-000880-27-HUovartis Pharma Services AG118
进行中（未招募）
不适用
A Phase II Study Of Oral LBH589 In Adult Patients With Refractory Cutaneous T-Cell LymphomaAdult patients with stages IB to IVA mycosis fungoides (MF) or Sézary syndrome (SS). All patients must have received at least two prior treatment regimens for their MF or SS, at least one of which was a systemic regimen.MedDRA version: 8.1Level: LLTClassification code 10011679Term: Cutaneous T-cell lymphoma refractoryEUCTR2006-000880-27-DEovartis Pharma Services AG132
进行中（未招募）
不适用
A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of TherapyPatients with relapsed multiple myeloma who have received at least two prior lines of therapy and whose disease is refractory to the most recent line of therapy. Prior therapy must have included bortezomib or lenalidomide.MedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2006-004087-31-DEovartis Pharma Services AG144