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    Association details:
    Biomarker:CD19 positive
    Cancer:Acute Lymphocytic Leukemia
    Drug:Blincyto (blinatumomab) (CD3 agonist, CD19 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    11/23/2015
    Excerpt:
    BLINCYTO is indicated for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B‑precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Treatment of Older Patients With B-precursor ALL With Sequential Dose Reduced Chemotherapy and Blinatumomab

    Excerpt:
    ...Patients with newly diagnosed CD19 positive B-precursor ALL 2....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL

    Excerpt:
    ...101 Immunophenotypic evidence of CD19 positive B-precursor ALL (pro B-, pre B-, common ALL) 102 Age > 28 days and < 18 years at the time of informed consent/assent 103 Morphological or molecular evidence of relapsed/refractory disease, defined as one of the following:...
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Blinatumomab in infant acute lymphoblastic leukemia (ALL)n

    Excerpt:
    ...Patients must have newly diagnosed, CD19 positive, B-precursor ALL...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia

    Excerpt:
    ...Patients with CD19 positive B-precursor ALL in complete hematological remission defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks (e.g., GMALL induction I-II/consolidation I)....
    Trial ID:
    NCT03109093
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults.

    Excerpt:
    ...- Primary CD19 (cluster of differentiation antigen 19) positive precursor B-ALL (excluding mature B-cell ALL and B-lymphoblastic lymphoma, but including Philadelphia positive/BCR-ABL (Abelson murine leukemia viral oncogene homolog 1) positive ALL) and CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL);...
    Trial ID:
    HOVON146ALL
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Blinatumomab in Pediatric B-cell Acute Lymphoblastic Leukemia (ALL) With Minimal Residual Disease (MRD)

    Excerpt:
    ...- Immunophenotypic evidence of Cluster of Differentiation 19 (CD19) positive B precursor ALL...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    PETHEMA-BLIN-01/PET069014 (BLIN-01)

    Excerpt:
    ...- Patients with Philadelphia chromosome-negative or BCR-ABL-negative, CD19-positive ALL, with high-risk characteristics....
    Trial ID:
    NCT03523429
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Blinatumomab in infant ALL

    Excerpt:
    ...Patients must have newly diagnosed, CD19 positive, B-precursor acute lymphoblastic leukemia 3. ...
    Trial ID:
    2016-004674-17
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    BLAM- A phase IIb study of Blinatumomab + Cytarabine (AraC) and Methotrexate in adult B-precursor Acute Lymphoblastic Leukaemia

    Excerpt:
    ...CD19 positive diseases...
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2021
    Title:

    Dose Reduced Chemotherapy in Sequence with Blinatumomab for Newly Diagnosed Older Patients with B-Precursor Adult Lymphoblastic Leukemia (ALL): Results of the Ongoing GMALL Bold Trial

    Published date:
    11/04/2021
    Excerpt:
    Pts aged 56 – 76 yrs with CD19-positive, Ph-neg B-precursor ALL are eligible….29 pts were evaluable for the primary endpoint after Blina 1. 24 were in hematologic CR (83%), 3 had failure (10%) and 2 experienced ED...82% of the CR pts (N=19) had a molecular response (69% MolCR). 8 / 9 pts with pro-B-ALL had a CR after Blina 1 (89%) and the molecular response rate was 62% (37% MolCR).... The 1y OS was 89% for c/pre-B-ALL and 75% for pro-B-ALL. OS was 100% at 1 yr for pts aged 55-65 yrs and 66% for those older than 65 yrs....Disease Free Survival was 89% at 1 yr. Blinatumomab was well tolerated. No death occurred during Blina 1.
    DOI:
    10.1182/blood-2021-146214
    Trial ID:
    EWALL-BOLD