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Therapy Name | Inotuzumab ozogamicin |
Synonyms | |
Therapy Description |
Besponsa (inotuzumab ozogamicin) consists of calecheamicin covalently linked to anti-CD22 antibody, which delivers calecheamicin into CD22-positive cells, potentially leading to DNA damage and apoptosis (PMID: 24389139). Besponsa (inotuzumab ozogamicin) is FDA-approved for use in adult and pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Inotuzumab ozogamicin | Besponsa | CMC-544|InO | CD22 Immune Cell Therapy 15 | Besponsa (inotuzumab ozogamicin) consists of calecheamicin covalently linked to anti-CD22 antibody, which delivers calecheamicin into CD22-positive cells, potentially leading to DNA damage and apoptosis (PMID: 24389139). Besponsa (inotuzumab ozogamicin) is FDA-approved for use in adult and pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT03104491 | Phase Ib/II | Inotuzumab ozogamicin | Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia | Recruiting | USA | 0 |
NCT03094611 | Phase II | Inotuzumab ozogamicin | Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia | Terminated | USA | 0 |
NCT03856216 | Phase II | Methotrexate Filgrastim + Methotrexate + Rituximab Rituximab Bendamustine + Fludarabine + Inotuzumab ozogamicin + Tacrolimus Filgrastim + Methotrexate Inotuzumab ozogamicin Fludarabine + Inotuzumab ozogamicin + Melphalan + Tacrolimus anti-thymocyte globulin | Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation | Recruiting | USA | 0 |
NCT03959085 | Phase III | Dexamethasone + Doxorubicin + Methotrexate + Pegaspargase + Vincristine Sulfate Cyclophosphamide + Cytarabine + Mercaptopurine + Methotrexate + Pegaspargase + Vincristine Sulfate Leucovorin + Mercaptopurine + Methotrexate + Vincristine Sulfate Inotuzumab ozogamicin Cytarabine + Daunorubicin + Dexamethasone + Methotrexate + Pegaspargase + Vincristine Sulfate Cytarabine + Daunorubicin + Methotrexate + Pegaspargase + Prednisolone + Vincristine Sulfate Cyclophosphamide + Cytarabine + Methotrexate + Pegaspargase + Thioguanine + Vincristine Sulfate Inotuzumab ozogamicin + Methotrexate Methotrexate + Pegaspargase + Vincristine Sulfate Mercaptopurine + Methotrexate + Prednisolone + Vincristine Sulfate | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy | Recruiting | USA | NZL | CAN | AUS | 1 |
NCT03913559 | Phase II | Inotuzumab ozogamicin Cytarabine + Hydrocortisone + Methotrexate Acetaminophen + Diphenhydramine + Methylprednisolone | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia | Recruiting | USA | 0 |
NCT01925131 | Phase I | Cyclophosphamide + Prednisone + Vincristine Sulfate Inotuzumab ozogamicin | S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia | Completed | USA | 0 |
NCT03460522 | Phase II | Inotuzumab ozogamicin | Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL | Recruiting | DEU | 0 |
NCT03677596 | FDA approved | Inotuzumab ozogamicin | A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients | Completed | USA | TUR | POL | HUN | ESP | 3 |
NCT01371630 | Phase Ib/II | Inotuzumab ozogamicin Cyclophosphamide + Cytarabine + Inotuzumab ozogamicin + Methotrexate + Vincristine Sulfate Mercaptopurine + Methotrexate + Prednisone + Vincristine Sulfate Rituximab Cytarabine + Inotuzumab ozogamicin + Methotrexate | Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia | Recruiting | USA | 0 |
NCT03441061 | Phase II | Inotuzumab ozogamicin | Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease | Recruiting | USA | 0 |
NCT03150693 | Phase III | Rituximab Doxorubicin Mercaptopurine Methotrexate Cyclophosphamide + Cytarabine Thioguanine Allopurinol Daunorubicin Dexamethasone Vincristine Sulfate Inotuzumab ozogamicin | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia | Suspended | USA | CAN | 0 |
NCT05748171 | Phase II | Asparaginase + Dexamethasone + Mitoxantrone + Vincristine Sulfate Inotuzumab ozogamicin | A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL | Recruiting | SWE | SVK | POL | NOR | NLD | ITA | ISR | HUN | FRA | FIN | ESP | DNK | DEU | CZE | CHE | BEL | AUT | 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 |
NCT03488225 | Phase II | Mercaptopurine + Methotrexate + Prednisone + Vincristine Sulfate Cytarabine + Leucovorin + Methotrexate Inotuzumab ozogamicin Ofatumumab Rituximab Cytarabine + Doxorubicin + Methotrexate + Vincristine Sulfate Pegfilgrastim Cyclophosphamide + Dexamethasone + Mesna | Hyper-CVAD in Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With Acute Lymphocytic Leukemia | Terminated | USA | 0 |
NCT02981628 | Phase II | Inotuzumab ozogamicin | Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia | Recruiting | USA | 1 |