EUCTR2009-012152-24-GB进行中（未招募）不适用
A PHASE II, MULTICENTER, RANDOMIZED, CONTROLLED, OPEN-LABEL STUDY OF THE SAFETY, EFFICACY AND PHARMACOKINETICS OF ABT-263 IN COMBINATION WITH RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH B-CELL, CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Signed informed consent
- •Age = 18 years
- •Previously untreated, CD20-positive B-cell CLL, as defined above, and one or
- •more criteria that dictate the need for treatment
- •ECOG performance status of 0 or 1; patients with an ECOG performance status of 2 due solely to their CLL disease are also eligible to be enrolled
- •Life expectancy > 6 months
- •Willingness and capability to be accessible for follow-up until study termination
- •For patients of reproductive potential (both males and females), use of a
- •reliable means of contraception
- •Laboratory values within limits specified in the protocol
- •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
- •Prolymphocytic leukemia
- •Richter’s transformation to an aggressive B-cell malignancy (e.g., DLBCL)
- •Prior radiotherapy to a lesion(s) that will be used to assess response
- •Patients with a history of other malignancies within 2 years prior to study entry except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade, localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy alone with curative intent
- •Prior treatment with rituximab, ABT-263 or other pro-apoptotic agents (e.g. Bcl-2 inhibitors)
- •Current or recent (within the 28 days prior to initiation of study treatment) participation in another experimental drug study
- •Receipt of primary or booster vaccination with live-virus vaccines for up to 6 months prior to initiation of study treatment
- •Patients receiving therapeutic anticoagulation with heparin or warfarin or patients receiving any drugs or herbal supplements that are known to inhibit platelet function (including low-dose aspirin) within 7 days of the first dose of ABT-263. Note: patients receiving low-dose anticoagulation for the purpose of maintaining central venous catheter patency are eligible.
- •Known human immunodeficiency virus (HIV) infection, seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or RNA.
- •Hisotry of anaphylaxis, allergic reaction or hypersensitivity to sulfites (sodium metabisulphite is included in study drug formulation).
- •Any contraindicationto alcohol ingestion (study drug formulation includes approximately 15% ethanol).
研究者
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