NL-OMON46935已完成2 期
A Phase 2b , Open-Label Study of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) - SADAL: Selinexor Against Diffuse Aggressive Lymphoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients, age *18 years, with pathologically confirmed or transformed DLBCL whose disease is R/R, with documented evidence of disease progression (according to the revised criteria for response assessment of lymphoma (Cheson, 2014) 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. If the patient*s most recent systemic anti DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy; otherwise at least 14 weeks (98 days) must have elapsed since the end of their most recent systemic anti-DLBCL therapy. Patients must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their DLBCL including at least 1 course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine, or gemcitabine must have been given) and at least 1 course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Patients who were considered ineligible for standard multi-agent immunochemotherapy must have received at least 2 (but no more than 5) previous systemic regimens including at least 1 course of anti CD20 antibodies and must be approved by the Medical Monitor. 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.
排除标准
- •Patients with DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, composite lymphoma (Hodgkin*s lymphoma [HL]+ non-Hodgkin*s lymphoma [NHL]), or DLBCL transformed from diseases other than indolent NHL are excluded from this study. Primary mediastinal (thymic) large B-cell lymphoma (PMBL) and central nervous system lymphoma are excluded. Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation and documentation for ineligibility must be provided. Patients with hemoglobin <10.0 g/dL, a circulating lymphocyte count >50,000/*L, or who have had a red blood cell transfusion within 14 days prior to and including Cycle 1 Day 1 are excluded.
研究者
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