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 16 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
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
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
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
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
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
NCT03677596 FDA approved Inotuzumab ozogamicin A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients Completed USA | ESP 6
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
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
NCT03460522 Phase II Inotuzumab ozogamicin Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL Recruiting DEU 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 NLD | ITA | FRA | ESP | DEU | BEL | AUT 11
NCT03441061 Phase II Inotuzumab ozogamicin Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease Recruiting USA 0


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