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

Centre Hospitalier de Versailles0 个研究点目标入组 130 人开始时间: 2017年7月21日最近更新: 2017年8月21日

试验速览

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•- 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.
•- Eligible for National Health Insurance in France.
•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

•- Concurrent therapy with any other investigational agent or cytotoxic drug,
•- 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 study drug.
•- 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,
•- Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study.

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