Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Inclusion Criteria:

* Morphologic evidence of B-precursor ALL with \> 25% blasts in bone marrow (M3) at study enrolment
* Age less than 18 years at enrollment
* Relapsed/refractory disease:

  * Second or later bone marrow relapse,
  * Any marrow relapse after allogeneic hematopoietic stem cell transplantation (HSCT), or
  * Refractory to other treatments: Patients in first relapse must have failed to achieve a CR following full standard reinduction chemotherapy regimen of at least 4 weeks duration. Patients who have not achieved a first remission must have failed a full standard induction regimen
* Karnofsky performance status more than or equal to 50% for patients more than or equal to 16 years and Lansky Performance Status (LPS) of more than or equal to 50% for patients less than 16 years
* Organ function requirements: All patients must have adequate renal and liver functions

Exclusion Criteria:

* Active acute or extensive chronic graft-versus-host disease (GvHD)
* Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment
* Evidence for current central nervous system (CNS) involvement by ALL (CNS 2, CNS 3) or testicular involvement by ALL
* History of relevant CNS pathology or current relevant CNS pathology
* History of autoimmune disease with potential CNS involvement or current autoimmune disease
* Any HSCT within 3 months prior to blinatumomab treatment
* Cancer chemotherapy within 2 weeks prior to blinatumomab treatment (except for intrathecal chemotherapy and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids)
* Chemotherapy related toxicities that haven't resolved to less than or equal to Grade 2
* Radiotherapy within 2 weeks prior to blinatumomab treatment
* Immunotherapy (e.g. rituximab, alemtuzumab) within 6 weeks prior to blinatumomab treatment
* Any investigational product within 4 weeks prior to study entry
* Previous treatment with blinatumomab
* Active severe infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
* Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)