EUCTR2014-001977-15-ES进行中（未招募）不适用
A Phase 2b Open-label, Randomized, Two-arm Study of Selinexor (KPT-330) with Low Dose Dexamethasone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) - SADAL: Selinexor and Dexamethasone (Sel-Dex) in Aggressive 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
- 200
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
- •Patients, age ? 18 years, with pathologically confirmed DLBCL whose disease is relapsed and/or refractory, with documented evidence of disease progression after the most recently administered chemotherapy regimen (according to International Working Group (IWG) criteria for progression of lymphoma, Cheson 2007), and who in the opinion of the investigator are not candidates for high-dose chemotherapy with autologous stem cell rescue, may be considered for enrollment. Patients must have received at least 2 but no more than 4 previous systemic multi-agent regimens for the treatment of their DLBCL including at least one course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case etoposide must have been given) and at least two courses of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy. Patients should have an estimated life expectancy of more than 3 months at study entry. Patients will undergo a pre-screening biopsy to confirm DLBCL histology, define DLBCL subtype (GCB or non-GCB) as well as DH-DLBCL status (Myc, BCL2, and BCL6 translocation and expression).
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Patients with histologies other than de novo DLBCL, (i.e., patients with DLBCL transformed from indolent lymphomas, primary mediastinal (thymic) large B-cell lymphoma (PMBL), or active central nervous system (CNS) lymphoma, will be excluded from this study. Patients with severe intolerance to glucocorticoids (e.g., due to uncontrolled diabetes mellitus) who are unable to receive a minimum dose of 8 mg of dexamethasone twice weekly (i.e., with each dose of selinexor) are also excluded from this study. Patients must not be eligible for high-dose therapy with stem cell rescue and documentation for ineligibility must be provided.
研究者
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