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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 19 | 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 |
---|---|---|---|---|---|---|---|
KMT2A rearrange | childhood B-cell acute lymphoblastic leukemia | predicted - sensitive | Blinatumomab | Phase II | Actionable | In a Phase II trial, Blincyto (blinatumomab) treatment followed by a chemotherapy regimen with Cytoxan (cyclophosphamide), Cytosar-U (cytarabine), Mercaptopurine, MARMA, and OCTADAD demonstrated safety and resulted in minimal residual disease-negative or low in 93% (28/30) of infant patients with KMT2A-rearranged, B-precursor, acute lymphoblastic leukemia after infusion with Blincyto (blinatumomab), and a 2-year disease-free survival of 81.6% and an overall survival of 93.3% (PMID: 37099340). | 37099340 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 | Active, not recruiting | USA | AUS | 0 |
NCT04556084 | Phase II | Blinatumomab | Blinatumomab Bridging Therapy | 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 | Active, not recruiting | USA | 0 |
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 |
NCT04521231 | Phase I | Blinatumomab | A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | AUT | AUS | 2 |
NCT04746209 | Phase II | Blinatumomab | Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT | Recruiting | USA | 0 |
NCT05848687 | Phase Ib/II | Bortezomib Dexamethasone Blinatumomab Vorinostat Mercaptopurine Pegaspargase Methotrexate Ziftomenib Mitoxantrone | TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II | Not yet 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 | Active, not recruiting | USA | 0 |
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 |
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 | AUS | 2 |
NCT04307576 | Phase III | Imatinib Blinatumomab Inotuzumab ozogamicin | A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia | Recruiting | GBR | FRA | DEU | BEL | 10 |
NCT04506086 | FDA approved | Blinatumomab | Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) | Recruiting | USA | 0 |
NCT03751709 | Phase I | Blinatumomab | Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL | Active, not recruiting | USA | 0 |
NCT04785547 | Phase II | Blinatumomab | ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT | Unknown status | ITA | FRA | ESP | BEL | AUT | 6 |
NCT02458014 | Phase II | Blinatumomab | Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease | Active, not recruiting | USA | 0 |
NCT04827745 | Phase II | Blinatumomab | Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL | Active, not recruiting | USA | 0 |
NCT04994717 | Phase III | Blinatumomab | Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia | Recruiting | USA | ITA | FRA | ESP | DEU | BEL | AUT | AUS | 11 |