Therapy Detail

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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).

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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).

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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
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
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
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
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
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
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
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
NCT03913559 Phase II Inotuzumab ozogamicin Cytarabine + Hydrocortisone + Methotrexate Acetaminophen + Diphenhydramine + Methylprednisolone Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia 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
NCT03460522 Phase II Inotuzumab ozogamicin Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL Recruiting DEU 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
NCT03441061 Phase II Inotuzumab ozogamicin Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease 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
NCT03104491 Phase Ib/II Inotuzumab ozogamicin Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia Recruiting USA 0


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