InO - A Retrospective Study of UK Patients With Leukaemia
NCT ID: NCT04456959
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
28 participants
OBSERVATIONAL
2020-01-06
2021-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Adult R/R ALL patients who have received InO
Relapsed/refractory ALL patients who are 18 years and over and initiated InO between 1st of June 2016 and date of data collection (to be confirmed). They will have accessed InO treatment via NHS commissioning, via the CUP, or via private purchase and will have at least 3 months follow up from the index date unless death occurs within that time.
Inotuzumab Ozogamicin
Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Interventions
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Inotuzumab Ozogamicin
Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who initiated InO between 1st of June 2016 and date of data collection.
* Patients who accessed InO treatment via NHS commissioning, via the CUP, or via private purchase.
* Patient aged ≥18 years old at initiation of InO treatment
Exclusion Criteria
* Patients with \<3 months of follow-up since index date, unless death occurs \<3 months from index date.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
University College London Hospital NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust of Fulham Road
London, , United Kingdom
Taunton and Somerset NHS Foundation Trust of Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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X9001222
Identifier Type: -
Identifier Source: org_study_id
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