Inotuzumab ozogamicin
- Generic Name
- Inotuzumab ozogamicin
- Brand Names
- Besponsa
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 635715-01-4
- Unique Ingredient Identifier
- P93RUU11P7
- Background
Inotuzumab ozogamicin is an antibody-drug conjugate using linker and cytotoxic drug technology similar to that developed for the ground-breaking treatment Mylotarg (Gemtuzumab ozogamicin), which was approved by the US FDA in 2000 for the treatment of acute myeloid leukaemia. Inotuzumab ozogamicin consists of a recombinant humanised IgG4 kappa CD22-targeting ...
- Indication
Indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).
- Associated Conditions
- Refractory B-cell precursor acute lymphoblastic leukemia, Relapsed B cell precursor Acute lymphoblastic leukemia
- Associated Therapies
- -
Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
- Conditions
- Interventions
- First Posted Date
- 2022-07-13
- Last Posted Date
- 2022-07-13
- Target Recruit Count
- 31
- Registration Number
- NCT05456698
Venetoclax Plus Inotuzumab for B-ALL
- Conditions
- Interventions
- First Posted Date
- 2021-08-23
- Last Posted Date
- 2024-08-14
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 26
- Registration Number
- NCT05016947
- Locations
- ๐บ๐ธ
Dana Farber Cancer Institute, Boston, Massachusetts, United States
๐บ๐ธBrigham and Women's Hospital, Boston, Massachusetts, United States
Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
- Conditions
- Interventions
- First Posted Date
- 2021-02-10
- Last Posted Date
- 2024-11-22
- Lead Sponsor
- University of Chicago
- Target Recruit Count
- 25
- Registration Number
- NCT04747912
- Locations
- ๐บ๐ธ
University of Chicago Medical Center, Chicago, Illinois, United States
InO - A Retrospective Study of UK Patients With Leukaemia
- Conditions
- Interventions
- First Posted Date
- 2020-07-07
- Last Posted Date
- 2022-09-28
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 28
- Registration Number
- NCT04456959
- Locations
- ๐ฌ๐ง
University College London Hospital NHS Foundation Trust, London, United Kingdom
๐ฌ๐งUniversity Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom
๐ฌ๐งThe Royal Marsden NHS Foundation Trust of Fulham Road, London, United Kingdom
Besponsa Post Marketing Surveillance Study
- First Posted Date
- 2020-03-13
- Last Posted Date
- 2024-03-19
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 160
- Registration Number
- NCT04307134
- Locations
- ๐ฐ๐ท
Pfizer, Seoul, Korea, Republic of
Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL
- Conditions
- Interventions
- First Posted Date
- 2019-05-24
- Last Posted Date
- 2023-08-22
- Lead Sponsor
- University of Virginia
- Target Recruit Count
- 36
- Registration Number
- NCT03962465
- Locations
- ๐บ๐ธ
University of Wisconsin, Madison, Wisconsin, United States
๐บ๐ธUniversity of Virginia, Charlottesville, Virginia, United States
๐บ๐ธVanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
- Conditions
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Calaspargase PegolProcedure: Bone ScanDrug: CyclophosphamideProcedure: Computed TomographyDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: CytarabineDrug: Doxorubicin HydrochlorideDrug: Leucovorin CalciumBiological: Inotuzumab OzogamicinDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseProcedure: Magnetic Resonance ImagingDrug: PrednisoloneOther: Questionnaire AdministrationRadiation: Radiation TherapyProcedure: Positron Emission TomographyDrug: ThioguanineDrug: Vincristine Sulfate
- First Posted Date
- 2019-05-22
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 4997
- Registration Number
- NCT03959085
- Locations
- ๐บ๐ธ
Henry Ford Health Saint John Hospital, Detroit, Michigan, United States
๐บ๐ธMichigan State University Clinical Center, East Lansing, Michigan, United States
๐บ๐ธCorewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States
Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
- First Posted Date
- 2019-04-12
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- St. Jude Children's Research Hospital
- Target Recruit Count
- 32
- Registration Number
- NCT03913559
- Locations
- ๐บ๐ธ
Rady Children's Hospital San Diego, San Diego, California, United States
๐บ๐ธSt. Jude Children's Research Hospital, Memphis, Tennessee, United States
Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation
- Conditions
- Interventions
- First Posted Date
- 2019-02-27
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 44
- Registration Number
- NCT03856216
- Locations
- ๐บ๐ธ
M D Anderson Cancer Center, Houston, Texas, United States
Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- First Posted Date
- 2018-11-14
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 64
- Registration Number
- NCT03739814
- Locations
- ๐บ๐ธ
Cancer Hematology Centers - Flint, Flint, Michigan, United States
๐บ๐ธUniversity of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
๐บ๐ธAnchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Drug Development Updates
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