Therapy Detail

Therapy Name inotuzumab ozogamicin
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
inotuzumab ozogamicin Besponsa CMC-544|InO Besponsa (inotuzumab ozogamicin) consists of calecheamicin covalently linked to anti-CD22 antibody, which delivers calecheamicin into CD22-positive cells, leading to DNA damage and apoptosis (PMID: 24389139). Besponsa (inotuzumab ozogamicin) is FDA approved for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown B-cell adult acute lymphocytic leukemia not applicable inotuzumab ozogamicin FDA approved Actionable In a Phase III trial supporting FDA approval, Besponsa (inotuzumab ozogamicin) treatment resulted in a significantly improved complete remission rate (80.7%, 88/109), duration of remission (4.6 months), progression free survival (5.0 months) and overall survival (7.7 months) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia when compared to standard of care (29.4%, 24/109, 3.1, 1.8, 6.7 months, respectively) (PMID: 27292104; NCT01564784). 27292104
Clinical Trial Phase Therapies Title Recruitment Status
NCT03094611 Phase II inotuzumab ozogamicin Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia Recruiting
NCT01925131 Phase I Cyclophosphamide + Prednisone + Vincristine inotuzumab ozogamicin S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia Recruiting
NCT03441061 Phase II inotuzumab ozogamicin Study of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease Recruiting
NCT03488225 Phase II Mercaptopurine + Methotrexate + Prednisone + Vincristine Methotrexate + Cytarabine + Leucovorin inotuzumab ozogamicin Ofatumumab Rituximab Cytarabine + Doxorubicin + Methotrexate + Vincristine Pegfilgrastim Cyclophosphamide + Dexamethasone + Mesna Hyper-CVAD in Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With Acute Lymphocytic Leukemia Recruiting
NCT03150693 Phase III Rituximab Doxorubicin Mercaptopurine Methotrexate Cyclophosphamide + Cytarabine Thioguanine Allopurinol Daunorubicin Dexamethasone Vincristine inotuzumab ozogamicin Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia Recruiting
NCT03104491 Phase Ib/II inotuzumab ozogamicin Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia Suspended
NCT02981628 Phase II inotuzumab ozogamicin Inotuzumab Ozogamicin in Treating Younger Patients With Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia Recruiting
NCT03856216 Phase II Methotrexate Filgrastim + Methotrexate + Rituximab Rituximab Bendamustine + Fludarabine phosphate + Inotuzumab ozogamicin + Tacrolimus Filgrastim + Methotrexate inotuzumab ozogamicin Fludarabine phosphate + Inotuzumab ozogamicin + Melphalan + Tacrolimus anti-thymocyte globulin Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplant Not yet recruiting
NCT01371630 Phase Ib/II inotuzumab ozogamicin Ara-C + Cyclophosphamide + Inotuzumab ozogamicin + Methotrexate + Vincristine Mercaptopurine + Methotrexate + Prednisone + Vincristine Rituximab Cytarabine + Inotuzumab ozogamicin + Methotrexate Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia Recruiting