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 20 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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 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
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 NLD | ITA | FRA | DEU | BEL | AUT | AUS 11
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14
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
NCT04785547 Phase II Blinatumomab ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT Terminated ITA | FRA | ESP | BEL | AUT 5
NCT04827745 Phase II Blinatumomab Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL Active, not 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 | NZL | CAN | AUS 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
NCT04556084 Phase II Blinatumomab Blinatumomab Bridging Therapy Recruiting USA 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) Recruiting USA 0
NCT04521231 Phase I Blinatumomab A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients Recruiting USA | NLD | ITA | FRA | ESP | DEU | CAN | AUT | AUS 2
NCT04746209 Phase II Blinatumomab Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT Recruiting USA 0
NCT04307576 Phase III Imatinib Blinatumomab Inotuzumab ozogamicin A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia Recruiting NLD | GBR | FRA | DEU | BEL 9
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
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
NCT02458014 Phase II Blinatumomab Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease Active, not recruiting USA 0


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