Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Blinatumomab
Intervention description: Continuous intravenous infusion over four weeks per treatment cycle
Intervention MeSH terms: Blinatumomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: B-ALL; relapsed ALL; refractory ALL; adult ALL; Leukemia; Leukemia, Lymphoid; precursor cell lymphoblastic leukemia-lymphoma; Lymphatic diseases; Lymphoproliferative disorders; bispecific antibody; anti-CD19; Immunotherapeutic treatment; immunoproliferative disorders

Summary:

      The purpose of this study is to confirm whether the bispecific T cell engager antibody
      blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or
      refractory Acute Lymphoblastic Leukemia (ALL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Philadelphia chromosome (Ph)-negative B-precursor ALL, with any of the
             following:

               -  relapsed or refractory with first remission duration less than or equal to 12
                  months in first salvage or

               -  relapsed or refractory after first salvage therapy or

               -  relapsed or refractory within 12 months of allogeneic hematopoietic stem cell
                  transplantation (HSCT)

          -  10% or more blasts in bone marrow

          -  In case of clinical signs of additional extramedullary disease: measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Age ≥ 18 years

        Exclusion Criteria:

          -  Patients with Ph-positive ALL

          -  Patients with Burkitt's Leukemia according to World Health organization (WHO)
             classification

          -  History or presence of clinically relevant central nervous system (CNS) pathology

          -  Active ALL in the CNS or testes

          -  Current autoimmune disease or history of autoimmune disease with potential CNS
             involvement

          -  Autologous HSCT within six weeks prior to start of blinatumomab treatment

          -  Allogeneic HSCT within three months prior to start of blinatumomab treatment

          -  Any active acute graft versus-host disease (GvHD), or active chronic GvHD Grade 2 - 4

          -  Any systemic therapy against GvHD within two weeks prior to start of blinatumomab
             treatment

          -  Cancer chemotherapy within two weeks prior to start of blinatumomab treatment

          -  Radiotherapy within two weeks prior to start of blinatumomab treatment

          -  Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab
             treat-ment

          -  Any investigational anti-leukemic product within four weeks prior to start of
             blinatumomab treatment

          -  Treatment with any other investigational medicinal product (IMP) after signature of
             informed consent

          -  Eligibility for allogeneic HSCT at the time of enrollment

          -  Known hypersensitivity to immunoglobulins or to any other component of the IMP
             formulation

          -  Abnormal laboratory values indicative of inadequate renal or liver function

          -  History of malignancy requiring treatment other than ALL within five years prior to
             start of blinatumomab treatment with the exception of basal cell or squamous cell
             carcinoma of the skin, or carcinoma "in situ" of the cervix

          -  Any concurrent disease or medical condition that is deemed to interfere with the
             conduct of the study

          -  Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis
             B virus or hepatitis C virus

          -  Pregnant or nursing women

          -  Women of childbearing potential not willing to use an effective form of contraception.
             Male patients not willing to ensure not to beget a child

          -  Previous treatment with blinatumomab