InO - A Retrospective Study of UK Patients With Leukaemia
NCT04456959
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Patients with relapsed/refractory ALL.
- 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
- Patients initiated on treatment with InO at a different hospital than the ones
selected in this study.
- Patients with <3 months of follow-up since index date, unless death occurs <3 months
from index date.
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Descriptive Information | |||||
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Brief Title | InO - A Retrospective Study of UK Patients With Leukaemia | ||||
Official Title | A Retrospective Chart Review of UK Patients With Relapsed/Refractory Acute Lymphoblastic Leukaemia Treated With Inotuzumab Ozogamicin, a Real World Research Study | ||||
Brief Summary | The purpose of this study is to describe the demographics and clinical characteristics, treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with relapsed/refractory B-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin in the real-world. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients with relapsed/refractory Acute Lymphoblastic Leukemia who are aged 18 and over and initiated Inotuzumab Ozogamicin between 1st of June 2016 and date of data collection and received treatment via NHS commissioning, via the Compassionate Use Programme, or via private purchase. | ||||
Condition | Precursor Cell Lymphoblastic Leukemia-Lymphoma | ||||
Intervention | Drug: 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 Name: CMC-544 | ||||
Study Groups/Cohorts | 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. Intervention: Drug: Inotuzumab Ozogamicin | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment | 25 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2020 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04456959 | ||||
Other Study ID Numbers | X9001222 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | July 2020 |