EUCTR2011-002566-21-BE进行中（未招募）不适用
A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory C
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
- 163
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
- •Previous confirmation of B-cell CLL (including SLL) with a characteristic immunophenotype by flow cytometry.
- •Progressive disease after receiving at least one prior line of treatment (a minimum of one course of chemotherapy with rituximab) and not a candidate for HSC or BM transplant
- •Deemed a candidate for bendamustine/rituximab therapy by their
- •treating physician
- •Presence of symptomatic disease
- •Adequate hematological function
- •Adequate organ function
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
- •Exposure to Bendamustine within 180 days before drug administration
- •Any active secondary malignancy
- •Prior autologous or allogeneic stem cell transplantation SCT
- •Clinically significant abnormality on ECG
- •History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ or basal/squamous skin cancer.
- •Evidence of active infection
- •Documented current central nervous system involvement by leukemia or lymphoma
- •Having Richter's transformation or high-grade disease
- •Current pregnancy or lactation
- •History of yellow fever vaccination within three months prior to study enrollment
研究者
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