Therapy Detail

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Therapy Name Blinatumomab
Synonyms
Therapy Description

Blincyto (blinatumomab) is a bispecific antibody that binds both CD19 on B-cells and the CD3 complex on T-cells, therefore facilitates T-cell mediated killing of CD19-expressing tumor cells (PMID: 26337639). Blincyto (blinatumomab) is FDA approved for the treatment of B-cell precursor acute lymphoblastic leukemia in adult and children negative for BCR-ABL1 (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Blinatumomab Blincyto anti-CD19/anti-CD3 recombinant bispecific|monoclonal antibody MT103|MEDI-538 CD19 Antibody 10 Blincyto (blinatumomab) is a bispecific antibody that binds both CD19 on B-cells and the CD3 complex on T-cells, therefore facilitates T-cell mediated killing of CD19-expressing tumor cells (PMID: 26337639). Blincyto (blinatumomab) is FDA approved for the treatment of B-cell precursor acute lymphoblastic leukemia in adult and children negative for BCR-ABL1 (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown acute lymphoblastic leukemia not applicable Blinatumomab FDA approved Actionable In a Phase III trial that supported FDA approval, Blincyto (blinatumomab) treatment resulted in longer overall survival (7.7 vs 4.0 months), higher remission rate (34% vs 16%), and higher rate of event-free survival (31% vs 12%) compared to chemotherapy in patients with relapsed or refractory B-cell precursor acute lymphocytic leukemia (PMID: 28249141; NCT02013167). detail... 28249141
KMT2A - AFF1 B-cell acute lymphoblastic leukemia predicted - resistant Blinatumomab Case Reports/Case Series Actionable In a clinical case study, Blincyto (blinatumomab) treatment in a patient with B-lymphoblastic leukemia harboring KMT2A-AFF1 resulted in lineage switch as demonstrated by identification of myeloid sarcoma of the breast and acute myeloid leukemia within one month of treatment onset, along with mixed phenotype acute leukemia observed following cessation of treatment (PMID: 31885955). 31885955

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02790515 Phase II Sirolimus anti-thymocyte globulin Blinatumomab Tacrolimus Thiotepa Melphalan Fludarabine Cyclophosphamide Mesna Rituximab Filgrastim Provision of TCR?? T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation Recruiting USA 0
NCT02003222 Phase III Cytarabine Daunorubicin + Dexamethasone + Methotrexate + Pegaspargase + Vincristine Sulfate Mercaptopurine + Methotrexate + Prednisone + Vincristine Sulfate Cyclophosphamide + Cytarabine + Mercaptopurine + Pegaspargase Methotrexate + Pegaspargase Cytarabine + Etoposide + Methotrexate Rituximab Blinatumomab Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia Active, not recruiting USA | CAN 2
NCT03117751 Phase II Cyclophosphamide Vincristine Sulfate Idarubicin Blinatumomab Doxorubicin Clofarabine Vorinostat Ruxolitinib Prednisone Bortezomib Etoposide Dasatinib Daunorubicin Dexamethasone Rituximab Methotrexate Cytarabine Mercaptopurine Pegaspargase Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma Recruiting USA 0
NCT03147612 Phase II Pegfilgrastim Blinatumomab Vincristine Sulfate Rituximab Filgrastim Ponatinib Cyclophosphamide Methotrexate Cytarabine Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia Recruiting USA 0
NCT02143414 Phase II Mercaptopurine + Methotrexate + Prednisone + Vincristine Sulfate Dasatinib + Prednisone Blinatumomab + Dasatinib Blinatumomab Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia Suspended USA 0
NCT02101853 Phase III Blinatumomab Leucovorin + Pegaspargase + Vincristine Sulfate Mercaptopurine + Thioguanine Asparaginase + Cyclophosphamide + Etoposide Cytarabine + Dexamethasone + Methotrexate Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia Active, not recruiting USA | CAN 3
NCT03849651 Phase II TCR alpha/beta+/CD19+ depleted hematopoietic cells CD45RA-depleted donor lymphocytes anti-thymocyte globulin + Cyclophosphamide + Filgrastim + Fludarabine + Melphalan + Mesna + Thiotepa Blinatumomab TCRalphabeta-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies Recruiting USA 0
NCT03751709 Phase I Blinatumomab Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL Recruiting USA 0


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