Last updated on April 2018

Study of Inotuzumab Ozogamicin Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor ALL

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Lymphoblastic Leukemia (ALL) - Philadelphia Chromosome (Ph)-Negative CD22+ B-cell Precursor (BCP)
  • Age: Between 55 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patients aged more than 55 years old,
  • With confirmed diagnosis of BCP-ALL according to World Health Organisation (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, Fluorescence In Situ Hybridization (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.

Exclusion Criteria:

  • Concurrent therapy with any other investigational agent or cytotoxic drug,
  • Prior documented chronic liver disease,
  • Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) 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 months following the last dose of maintenance.
  • Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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