NL-OMON40516
已完成
不适用
An open-label, single arm, Phase Ib/II study of AEB071 (a protein kinase C inhibitor) and everolimus (mTOR inhibitor) in patients with CD79-mutant or ABC subtype diffuse large B-cell lymphoma - Ph Ib/II study of AEB071+Everolimus in patients with DLBC
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Diffuse Large B Cell Lymphoma
- 发起方
- ovartis
- 入组人数
- 4
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Diffuse large B\-cell lymphoma with activating mutations in CD79 (A or B subunits) or patients who are determined to be ABC\-subtype diffuse large B\-cell lymphoma (CD79 wildtype or CD79 mutant). DLBCL that arose from transformed indolent lymphoma is allowed.
- •2\.Prior treatment and relapse following chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible or who did not respond to chemotherapy may be considered for the study following a single regimen of chemotherapy such
- •as R\-CHOP or R\-EPOCH. There is no limit to number of prior therapies allowed.
- •a. Patients may be treated with localized radiation as long as measurable or evaluable disease remains at untreated sites
- •b. Patients may be treated with corticosteroids immediately prior to enrollment and during the course of study treatment as long as steroid treatment is tapered to a total daily dosage of 10mg or less of prednisone (or its equivalent) prior to AEB071 and everolimus administration.
- •3\.A representative formalin\-fixed paraffin embedded (FFPE) tumor sample (with enough material available to determine CD79 mutational status, molecular subtype status, and for gene sequencing) must be available for molecular testing along with a corresponding pathology report. An archival
- •tumor sample may be submitted. However, if not available, a new tumor biopsy obtained for the purpose of this study must be submitted instead
排除标准
- •1\.Treatment with strong inducers or inhibitors (medications and herbal supplements) of cytochrome P450 3A4/5 (CYP3A4/5\), or CYP3A4/5 substrates with a QT prolongation risk that cannot be discontinued at least 7 half\-lives (or if the half\-life is unknown, 14 days) prior to study drug
- •2\. Impaired cardiac function or clinically significant cardiac diseases
- •3\.Patients with impairment of GI function or GI disease that could interfere with the absorption of AEB071 or everolimus
- •4\.Patients with severe systemic infections, current or within the two weeks prior to initiation of AEB071\.
- •5\.Patients with a known history of Human Immunodeficiency Virus (HIV)
- •6\.Patients with poorly controlled diabetes as defined by a fasting serum glucose \> 2\.0 x ULN
- •7\.Pregnant or nursing (lactating) women or women of child\-bearing potential unless they are using highly effective methods of contraception during dosing and for a period after treatment is complete
- •8\.Patients with evidence of current central nervous system (CNS) involvement. Patients who have only had prophylactic intrathecal or intravenous chemotherapy against CNS disease are eligible.
- •9\.Significant symptomatic deterioration of lung function. If clinically indicated pulmonary function tests including measure of predicated lung volumes, such as diffusing capacity of the lung for carbon monoxide, and oxygen saturation at rest on room air, should be considered to exclude restrictive lung disease; pneumonitis or pulmonary infiltrates.
结局指标
主要结局
未指定
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