Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neoplasm, Residual
Intervention: Blinatumomab (MT103)
Intervention description: Administered by continuous intravenous (CIV) over 4 weeks per cycle
Intervention MeSH terms: Blinatumomab; Antibodies, Bispecific
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Minimal Residual Disease; adult ALL; immunotherapeutic treatment; anti-CD19 bispecific antibody derivative; Blinatumomab; MT103

Summary:

      The purpose of this study is to determine whether the bispecific T-cell engager (BiTE®)
      Blinatumomab (MT103) is effective in the treatment of ALL patients with minimal residual
      disease.
    

Eligibility criteria:

        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 German Multicenter Study Group on Adult Acute Lymphoblastic Leukemia (GMALL)
             standards or at any time outside GMALL standards.

          -  Patients must have a molecular marker for evaluation of minimal residual disease which
             is either Breakpoint cluster region/gene on human chromosome #9 (Bcr/abl) at any
             detection level or individual rearrangements of immunoglobulin or T-cell receptor
             (TCR)-genes measured by an assay with a sensitivity of minimum 10^-4: At least one
             individual marker at a quantitative level ≥ 10^-4.

          -  Eastern Cooperative Oncology Group (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 central nervous system (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 vinca alkaloids,
             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 during participation in the study and at
             least three months thereafter