EUCTR2013-005343-82-IT进行中（未招募）1 期
An Expanded Access Protocol for Idelalisib in Combination with Rituximab for Relapsed, Previously Treated Subjects with Chronic Lymphocytic Leukemia
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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) Male or female =18 years of age with a diagnosis of B-cell CLL established according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.
- •2) CLL that warrants treatment (consistent with accepted IWCLL criteria for initiation of therapy).
- •3) Prior treatment for CLL comprising any of the following:
- •a) Prior treatment with =1 regimen containing a therapeutic anti-CD20 antibody or
- •b) Prior treatment with =2 regimens containing =1 cytotoxic agent
- •4) CLL progression <24 months since the completion of the last prior therapy for CLL.
- •5) Appropriate for non-cytotoxic-containing therapy based on the presence of any of the following factors:
- •a) Grade =3 neutropenia or thrombocytopenia attributable to cumulative myelotoxicity from prior administration of
- •cytotoxic agents (as documented by bone marrow biopsy obtained since last prior therapy), or
- •b) Estimated creatinine clearance (eCCr) <60 mL/min (as determined by the Cockcroft-Gault method), or
- •c) A Cumulative Illness Rating Scale (CIRS) score of >6
- •6) A negative serum pregnancy test for female subjects of child bearing potential
- •7) Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
- •8) Lactating females must agree to discontinue nursing before the IMP is administered.
- •9) Evidence of a personally signed informed consent.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1) Known hypersensitivity to the IMP, the metabolites, or formulation excipient.
- •2) Known histological transformation from CLL to an aggressive lymphoma (i.e., Richter transformation).
- •3) Known myelodysplastic syndrome.
- •4) Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization.
- •5) Ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- •6) Ongoing drug-induced pneumonitis.
- •7) Ongoing inflammatory bowel disease.
- •8) History of anaphylaxis in association with previous administration of monoclonal antibodies.
研究者
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