Inotuzumab ozogamicin
- Generic Name
- Inotuzumab ozogamicin
- Brand Names
- Besponsa
- Drug Type
- Biotech
- 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 monoclonal antibody covalently attached to calicheamicin derivative, N-acetyl-gamma-calicheamicin dimethylhydrazide, which is a potent DNA-binding cytotoxic agent . Developed by Pfizer and UCB, inotuzumab ozogamicin was granted approval by EU in June 2017 followed by FDA on August 17th, 2017 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ALL is a rapidly progressing cancer of the bone marrow that is associated with high mortality rates and low therapeutic response from standard chemotherapies in relasping conditions. In a randomized trial, inotuzumab ozogamicin displayed higher percentages of patients undergoing longer periods of complete remission with no evidence of disease in comparison to patients receiving alternative chemotherapy .
- 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
Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
- First Posted Date
- 2022-07-13
- Last Posted Date
- 2025-03-13
- Target Recruit Count
- 31
- Registration Number
- NCT05456698
- Locations
- ๐จ๐ณ
Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma
- Conditions
- B Acute Lymphoblastic LeukemiaB Lymphoblastic Lymphoma
- Interventions
- First Posted Date
- 2022-03-31
- Last Posted Date
- 2025-04-02
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 68
- Registration Number
- NCT05303792
- Locations
- ๐บ๐ธ
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
๐บ๐ธOregon Health and Science University, Portland, Oregon, United States
๐บ๐ธMarshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Venetoclax Plus Inotuzumab for B-ALL
- Conditions
- B-cell Acute Lymphoblastic LeukemiaB-Cell LymphomaALL
- Interventions
- First Posted Date
- 2021-08-23
- Last Posted Date
- 2025-01-23
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 26
- Registration Number
- NCT05016947
- Locations
- ๐บ๐ธ
Brigham and Women's Hospital, Boston, Massachusetts, United States
๐บ๐ธDana Farber Cancer Institute, Boston, Massachusetts, United States
Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
- Conditions
- Lymphoblastic LeukemiaAcute Lymphoblastic Leukemiaph+ Acute Lymphoblastic Leukemia
- Interventions
- Procedure: Allogenic Stem Cell Transplantation
- First Posted Date
- 2021-02-10
- Last Posted Date
- 2025-03-07
- 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
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- 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
- 2025-03-27
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 108
- 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
- B-cell Acute Lymphoblastic Leukemia
- 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
- Testicular LeukemiaB Lymphoblastic LymphomaB Acute Lymphoblastic LeukemiaMixed Phenotype Acute LeukemiaCentral Nervous System Leukemia
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Bone ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingOther: Questionnaire AdministrationRadiation: Radiation TherapyProcedure: Positron Emission Tomography
- First Posted Date
- 2019-05-22
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 4997
- Registration Number
- NCT03959085
- Locations
- ๐บ๐ธ
Children's Hospital of Alabama, Birmingham, Alabama, United States
๐ต๐ทHIMA San Pablo Oncologic Hospital, Caguas, Puerto Rico
๐บ๐ธMiami Cancer Institute, Miami, Florida, United States
Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- 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
- Acute Lymphoblastic LeukemiaB Acute Lymphoblastic LeukemiaLymphocytic NeoplasmLymphoma
- Interventions
- Procedure: Allogeneic Bone Marrow TransplantationProcedure: Peripheral Blood Stem Cell Transplantation
- First Posted Date
- 2019-02-27
- Last Posted Date
- 2025-04-01
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.