EUCTR2009-012152-24-PL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 DOSE-INTENSIVE RITUXIMAB, OR DOSE-INTENSIVE RITUXIMAB ALONE, IN PREVIOUSLY UNTREATED PATIENTS WITH B-CELL, CRONIC LYMPHOTIC LEUKEMIA (CLL) - FRANC
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 (with and without radiation as a complementary therapy)
- •with curative intent
- •Prior treatment with rituximab, ABT-263 or other investigational 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
- •Receipt of primary or booster vaccination with live-virus vaccines for up to 6 months prior to initiation of study
- •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.
- •History of anaphylaxis, allergic reaction, or hypersensitivity to sulfites
- •(sodium metabisulphite is included in study drug formulation)
- •Any contraindication to alcohol ingestion (study drug formulation includes
- •approximately 15% ethanol)
研究者
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