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
Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- Conditions
- Refractory B Acute Lymphoblastic LeukemiaB Acute Lymphoblastic Leukemia, Philadelphia Chromosome NegativeRecurrent B Acute Lymphoblastic Leukemia
- Interventions
- First Posted Date
- 2018-11-14
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 64
- Registration Number
- NCT03739814
- Locations
- ๐บ๐ธ
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
๐บ๐ธAnchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
๐บ๐ธAnchorage Radiation Therapy Center, Anchorage, Alaska, United States
Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL
- Conditions
- Precursor Cell Lymphoblastic Leukemia
- Interventions
- First Posted Date
- 2018-03-09
- Last Posted Date
- 2022-11-02
- Lead Sponsor
- Nicola Goekbuget
- Target Recruit Count
- 65
- Registration Number
- NCT03460522
- Locations
- ๐ฉ๐ช
Universitรคt Erlangen, Erlangen, Germany
๐ฉ๐ชKlinikum Augsburg, Augsburg, Germany
๐ฉ๐ชUniversity Hospital of Frankfurt, Frankfurt, Germany
Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
- Conditions
- B Acute Lymphoblastic LeukemiaRecurrent B Acute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia
- Interventions
- First Posted Date
- 2018-02-22
- Last Posted Date
- 2025-02-06
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 40
- Registration Number
- NCT03441061
- Locations
- ๐บ๐ธ
M D Anderson Cancer Center, Houston, Texas, United States
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
- Conditions
- B Acute Lymphoblastic Leukemia
- Interventions
- Procedure: Bone Marrow Aspiration and BiopsyOther: Laboratory Biomarker Analysis
- First Posted Date
- 2017-05-12
- Last Posted Date
- 2025-04-02
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 310
- Registration Number
- NCT03150693
- Locations
- ๐บ๐ธ
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
๐บ๐ธKatmai Oncology Group, Anchorage, Alaska, United States
๐บ๐ธFairbanks Memorial Hospital, Fairbanks, Alaska, United States
Inotuzumab Ozogamicin - PF-05208773
- First Posted Date
- 2017-04-25
- Last Posted Date
- 2020-05-18
- Lead Sponsor
- Pfizer
- Registration Number
- NCT03127605
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- First Posted Date
- 2017-04-07
- Last Posted Date
- 2025-01-10
- Lead Sponsor
- Leland Metheny
- Target Recruit Count
- 44
- Registration Number
- NCT03104491
- Locations
- ๐บ๐ธ
The University of Kansas Cancer Center, Westwood, Kansas, United States
๐บ๐ธDana-Farber Cancer Institute, Boston, Massachusetts, United States
๐บ๐ธUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
- Conditions
- Recurrent B Acute Lymphoblastic LeukemiaRecurrent B Lymphoblastic LymphomaRefractory B Acute Lymphoblastic LeukemiaRefractory B Lymphoblastic Lymphoma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration and BiopsyProcedure: Diagnostic ImagingProcedure: Lumbar Puncture
- First Posted Date
- 2016-12-05
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 80
- Registration Number
- NCT02981628
- Locations
- ๐บ๐ธ
Children's Hospital of Alabama, Birmingham, Alabama, United States
๐ต๐ทHIMA San Pablo Oncologic Hospital, Caguas, Puerto Rico
๐บ๐ธProvidence Alaska Medical Center, Anchorage, Alaska, United States
Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia
- Conditions
- B Acute Lymphoblastic LeukemiaB Lymphoblastic Lymphoma
- Interventions
- Other: Laboratory Biomarker Analysis
- First Posted Date
- 2016-08-24
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 80
- Registration Number
- NCT02877303
- Locations
- ๐บ๐ธ
M D Anderson Cancer Center, Houston, Texas, United States
Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- First Posted Date
- 2012-09-05
- Last Posted Date
- 2022-05-18
- Lead Sponsor
- University College, London
- Target Recruit Count
- 129
- Registration Number
- NCT01679119
- Locations
- ๐ฌ๐ง
North Hampshire Hospital, Basingstoke, United Kingdom
๐ฌ๐งWest Suffolk Hospital, Bury St Edmunds, United Kingdom
๐ฌ๐งUniversity Hospital, Coventry, Coventry, United Kingdom
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Drug: FLAG (fludarabine, cytarabine and G-CSF)Drug: HIDAC (high dose cytarabine)
- First Posted Date
- 2012-03-28
- Last Posted Date
- 2019-01-09
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 326
- Registration Number
- NCT01564784
- Locations
- ๐บ๐ธ
University of Kansas Cancer Center, Westwood, Kansas, United States
๐บ๐ธInvestigational Drug Services - UC San Diego Moores Cancer Center, La Jolla, California, United States
๐บ๐ธUC San Diego Medical Center - La Jolla, La Jolla, California, United States
Drug Development Updates
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