A Phase 1/2 Open-label Study to Investigate the Safety Efficacy and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults with Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

Are you eligible to participate in this study?

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

  • Conditions:
    Relapsed Or Refractory B Cell Precursor Acute Lymphoblastic Leukemia
  • Age: Between 12 Year(s) - 90 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    In order to participate in this study the following criteria must be met:
    1. Subjects with B-precursor ALL with any of the following: Either refractory to primary induction therapy or refractory to first, second, third, or more than third salvage therapy OR in untreated first, second, third or greater relapse or refractory relapse.
    2. Relapsed or Refractory at any time after first salvage therapy.
    3. Relapse at any time after allogeneic HSCT.

You may not be eligible for this study if the following are true:

  • You will not be able to participate in this study if you have had:
    1. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome or psychosis.
    2. Certian chemotherapy within 2 weeks before the start of protocol-specified therapy (excluding chemotherapy to cytoreduce the disease) or immunotherapy (eg, rituximab, alemtuzumab) within 4 weeks before start of protocol-specified therapy. Known hypersensitivity to blinatumomab or to any component of the product formulation.
    3. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus.



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