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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 use in adult and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL), CD19-positive B-cell precursor ALL in remission, and CD19-positive, BCR-ABL1-negative B-cell precursor ALL in the consolidation phase (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 21 | 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 use in adult and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL), CD19-positive B-cell precursor ALL in remission, and CD19-positive, BCR-ABL1-negative B-cell precursor ALL in the consolidation phase (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 |
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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 | Active, not recruiting | USA | 0 |
NCT03643276 | Phase III | Daunorubicin + Methotrexate + Pegaspargase + Prednisolone + Vincristine Sulfate Cyclophosphamide + Cytarabine + Dexamethasone + Mercaptopurine + Methotrexate + Pegaspargase + Vincristine Sulfate Blinatumomab + Mercaptopurine + Methotrexate Bortezomib + Cyclophosphamide + Cytarabine + Dexamethasone + Mercaptopurine + Methotrexate + Pegaspargase + Vincristine Sulfate Cyclophosphamide + Cytarabine + Mercaptopurine + Methotrexate Cyclophosphamide + Cytarabine + Daunorubicin + Dexamethasone + Etoposide + Ifosfamide + Methotrexate + Pegaspargase + Vincristine Sulfate + Vindesine Blinatumomab + Cyclophosphamide + Cytarabine + Dexamethasone + Methotrexate + Pegaspargase + Vincristine Sulfate Blinatumomab Cytarabine + Daunoxome + Fludarabine + Methotrexate Cyclophosphamide + Cytarabine + Dexamethasone + Doxorubicin + Methotrexate + Pegaspargase + Thioguanine + Vincristine Sulfate Mercaptopurine + Methotrexate Asparaginase Erwinia chrysanthemi Daunorubicin + Dexamethasone + Methotrexate + Pegaspargase + Vincristine Sulfate | Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 | Recruiting | SVK | ITA | ISR | DEU | CZE | CHE | AUT | AUS | 0 |
NCT04506086 | FDA approved | Blinatumomab | Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) | Terminated | USA | 0 |
NCT04746209 | Phase II | Blinatumomab | Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT | Recruiting | USA | 0 |
NCT04556084 | Phase II | Blinatumomab | Blinatumomab Bridging Therapy | 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 | TUR | SWE | ROU | NLD | ITA | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CHE | CAN | BRA | BGR | BEL | AUT | AUS | 6 |
NCT04785547 | Phase II | Blinatumomab | ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT | Terminated | SVK | POL | NOR | ITA | FRA | ESP | DNK | CZE | BEL | AUT | 0 |
NCT02458014 | Phase II | Blinatumomab | Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease | Active, not 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 | Recruiting | USA | CAN | 0 |
NCT04521231 | Phase I | Blinatumomab | A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients | Recruiting | USA | TUR | NLD | ITA | FRA | ESP | DEU | CAN | AUT | AUS | 1 |
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 | NZL | CAN | AUS | 1 |
NCT02790515 | Phase II | Sirolimus anti-thymocyte globulin Blinatumomab Tacrolimus Thiotepa Melphalan Fludarabine Cyclophosphamide Mesna Rituximab Filgrastim | Provision of TCRgammadelta 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 | Active, not 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 | ISR | CAN | 1 |
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 |
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 |
NCT04827745 | Phase II | Blinatumomab | Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL | Active, not recruiting | USA | 0 |
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 |
NCT03751709 | Phase I | Blinatumomab | Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL | Active, not recruiting | USA | 0 |
NCT04334993 | Phase II | Blinatumomab | Pediatric-type Therapy With Pre-transplant Blinatumomab for HR Patients - Phase II Study | Recruiting | ISR | 0 |
NCT04307576 | Phase III | Imatinib Blinatumomab Inotuzumab ozogamicin | A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia | Recruiting | SWE | NOR | NLD | LTU | ISL | IRL | GBR | FRA | FIN | EST | DNK | DEU | BEL | 1 |
NCT05327894 | Phase III | Blinatumomab | Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia (Interfant-21) | Recruiting | SWE | SVK | NOR | NLD | LTU | ITA | IRL | HUN | FRA | FIN | ESP | DNK | DEU | CZE | BEL | AUT | AUS | ARG | 4 |