InO - A Retrospective Study of UK Patients With Leukaemia

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NCT04456959

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Study Location
University Hospitals Bristol NHS Foundation Trust
Bristol, Somerset, BS1 3NU, United Kingdom
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Precursor Cell Lymphoblastic Leukemia-LymphomaInO - A Retrospective Study of UK Patients With Leukaemia
NCT04456959
  1. Bristol, Somerset
  2. Taunton, Somerset
  3. Sutton, Surrey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
 (submitted: June 29, 2020)		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:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020