Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute ALL

Inclusion Criteria:

• B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
• Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level ³10-4.
• ECOG Performance Status < 2
• Ability to understand and willingness to sign a written informed consent
• Signed and dated written informed consent is available

Exclusion Criteria:

• Current extra medullar involvement
• History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
• Current infiltration of cerebrospinal fluid by ALL
• History of or current autoimmune disease
• Autologous stem cell transplantation within 6 weeks prior to study entry
• Any prior allogeneic stem cell transplantation
• Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
• Radiotherapy within 4 weeks prior to study treatment
• Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
• Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
• Presence of human anti-murine antibodies (HAMA)
• Abnormal bone marrow, renal or hepatic function
• Indication for a hypercoagulative state
• History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
• Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
• Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
• Pregnant or nursing women
• Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter