EUCTR2016-004942-27-FI进行中（未招募）1 期
A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients with Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia - EWALL INO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
入选标准
- •- Patients aged more than 55 years old,
- •- With confirmed diagnosis of BCP-ALL according to WHO criteria
- •expressing the CD22 antigen by flow cytometry (20% or more positive
- •blast cells),
- •- Without central nervous system (CNS) involvement,
- •- Without BCR-ABL fusion by standard cytogenetics, FISH analysis
- •and/or RT-PCR,
- •- Previously untreated,
- •- Eligible to intensive chemotherapy, due to general health status,
- •- ECOG performance status = 2,
- •- Patients must have the following laboratory values unless considered
- •due to leukemia: AST and ALT = 2.5 x upper the limit of normal (ULN);
- •estimated GFR = 50 mL/min using the MDRD equation; total and direct
- •serum bilirubin = 1.5 x ULN; electrolyte panel within normal ranges for
- •the institution unless attributed to the underlying disease.
- •- Written informed consent obtained prior to any screening procedures.
- •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 130
排除标准
- •- Concurrent therapy with any other investigational agent or cytotoxic
- •- Prior documented chronic liver disease,
- •- Active HBV or HCV hepatitis or positive HIV serology,
- •- Female patients who are pregnant or breast feeding or patients of
- •childbearing potential not willing to use a double barrier method of
- •contraception during the study and for 3 months following the last dose of maintenance.
- •- Male patients whose sexual partner(s) are women of childbearing
- •potential who are not willing to use a double barrier method of
- •contraception, one of which includes a condom, during the study and for
- •3 month following the last dose of maintenance.
- •- Any of concurrent severe and/or uncontrolled medical condition, which
- •could compromise participation in the study.
研究者
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