Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia
Condition: Relapsed/Refractory Philadelphia Positive B-precursor ALL
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Blinatumomab
Intervention description: Blinatumomab is administered as a continuous intravenous infusion (CIV). A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab followed by a 2-week treatment-free interval.
Intervention MeSH terms: Blinatumomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed; Refractory; Philadelphia Positive; B-precursor; Acute Lymphoblastic Leukemia; ALL; Blinatumomab; Leukemia;

Summary:

      The primary objective is to evaluate the rate of complete remission/complete remission with
      partial hematological recovery (CRh*) in adults with relapsed/refractory Philadelphia
      chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive
      blinatumomab.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients with Ph+ B-precursor ALL, with any of the following:

               -  Relapsed or refractory to at least one second generation tyrosine kinase
                  inhibitor (TKI) (dasatinib, nilotinib, bosutinib, ponatinib)

               -  OR intolerant to second generation TKI and intolerant or refractory to imatinib
                  mesylate

          -  Greater than 5% blasts in bone marrow

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Age ≥ 18 years of age, at the time of informed consent.

          -  Subject has provided informed consent or subject's legally acceptable representative
             has provided informed consent when the subject has any kind of condition that, in the
             opinion of the Investigator, may compromise the ability of the subject to give written
             informed consent.

        Exclusion Criteria

          -  History of malignancy other than ALL within 5 years prior to start of
             protocol-required therapy, except for adequately treated selected cancers without
             evidence of disease

          -  History or presence of clinically relevant central nervous system (CNS) pathology as
             epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries,
             dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis

          -  Active ALL in the CNS or testes

          -  Isolated extramedullary disease

          -  Current autoimmune disease or history of autoimmune disease with potential CNS
             involvement

          -  Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before
             blinatumomab treatment

          -  Active acute or extensive chronic graft-versus-host disease (GvHD) which included the
             administration of immunosuppressive agents to prevent or treat GvHD within 2 weeks
             before blinatumomab treatment

          -  immediately previous cancer chemotherapy, radiotherapy, or immunotherapy; and
             eligibility for allogeneic HSCT at the time of enrollment.