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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). |
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). |
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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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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 |