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Trial record 1 of 1 for:    NCT04456959
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InO - A Retrospective Study of UK Patients With Leukaemia (InO)

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ClinicalTrials.gov Identifier: NCT04456959
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 8, 2020
First Posted Date July 7, 2020
Last Update Posted Date July 31, 2020
Actual Study Start Date January 6, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2020)
Clinical characteristics [ Time Frame: Through study completion, an average of 1 year ]
To describe patient demographic and clinical characteristics at initiation of Inotuzumab Ozogamicin
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 29, 2020)
  • Duration of treatment with InO [ Time Frame: Through study completion, an average of 1 year ]
    Description of the inotuzumab ozogamicin treatment pathway
  • Number of cycles of InO [ Time Frame: Through study completion, an average of 1 year ]
    Description of the inotuzumab ozogamicin treatment pathway
  • Interrupted cycles of InO, including reasons (liver toxicity TRAEs, other AEs, tolerance, treatment failure, and course complete). [ Time Frame: Through study completion, an average of 1 year ]
    Description of the inotuzumab ozogamicin treatment pathway
  • Doses of InO prescribed [ Time Frame: Through study completion, an average of 1 year ]
    Description of the inotuzumab ozogamicin treatment pathway
  • Modification of doses of InO, including reasons (liver toxicity TRAEs, other AEs, tolerance, treatment failure, and course complete). [ Time Frame: Through study completion, an average of 1 year ]
    Description of the inotuzumab ozogamicin treatment pathway
  • Azole antifungal therapy concomitant to InO treatment [ Time Frame: Through study completion, an average of 1 year ]
    Description of the inotuzumab ozogamicin treatment pathway
  • CR, CRi and CR/CRi response rates by the end of InO treatment, overall and according to the number of salvage therapies in the pre-index observation period (0, 1, ≥2); [ Time Frame: Through study completion, an average of 1 year ]
    To summarise CR/CRi rates following treatment with inotuzumab ozogamicin, overall and stratified according to the number of salvage therapies (0, 1, ≥2) received prior to inotuzumab ozogamicin initiation.
  • Median time to CR/CRi (95% CI) [ Time Frame: Through study completion, an average of 1 year ]
    To summarise median time to CR/CRi following treatment with inotuzumab ozogamicin
  • Number and proportion of patients achieving MRD negativity overall and by the number of completed cycles of InO (after 1, 2, ≥3 cycles of InO) in patients evaluated by flow-cytometry/ molecular assessment / both. [ Time Frame: Through study completion, an average of 1 year ]
    To summarise MRD negativity rates following initiation of inotuzumab ozogamicin, and describe the number of cycles of inotuzumab ozogamicin needed to attain MRD negativity.
  • The number and proportion of patients surviving at 3, 6 and 12 months after InO initiation [ Time Frame: Through study completion, an average of 1 year ]
    To describe overall survival, and cause of death; in all patients and in patient with or without follow-up hematopoietic stem-cell transplantation.
  • Cause of death [ Time Frame: Through study completion, an average of 1 year ]
    To describe overall survival, and cause of death; in all patients and in patient with or without follow-up hematopoietic stem-cell transplantation.
  • Median OS (95% CI) [ Time Frame: Through study completion, an average of 1 year ]
    To describe overall survival, and cause of death; in all patients and in patient with or without follow-up hematopoietic stem-cell transplantation.
  • The number and proportion of patients who are relapse-free at 3, 6 and 12 months after InO initiation; Median RFS (95% CI) In patients undergoing follow-up HSCT; Median NRM (95% CI) from the date of follow-up HSCT [ Time Frame: Through study completion, an average of 1 year ]
    To describe relapse-free-survival; in all patients and in patient with or without follow-up hematopoietic stem-cell transplantation.
  • Median RFS (95% CI) [ Time Frame: Through study completion, an average of 1 year ]
    To describe relapse-free-survival; in all patients and in patient with or without follow-up hematopoietic stem-cell transplantation.
  • In patients undergoing follow-up HSCT; Median NRM (95% CI) from the date of follow-up HSCT [ Time Frame: Through study completion, an average of 1 year ]
    Describe non-relapse mortality in patients undergoing follow-up hematopoietic stemcell transplantation. Median NRM (95% CI) from the date of follow-up HSCT
  • Document and report the number of patients who have received post-InO treatment including: new chemotherapy (blinatumomab, other), HSCT, CAR T cell therapy. [ Time Frame: Through study completion, an average of 1 year ]
    To describe the treatments for acute lymphoblastic leukaemia and responses to treatment post-inotuzumab ozogamicin, including hematopoietic stem cell transplantation, chemotherapy regimens and chimeric antigen receptor T-cell therapy.
  • In those who received post InO treatment recorded response to treatment and survival [ Time Frame: Through study completion, an average of 1 year ]
    To describe the treatments for acute lymphoblastic leukaemia and responses to treatment post-inotuzumab ozogamicin, including hematopoietic stem cell transplantation, chemotherapy regimens and chimeric antigen receptor T-cell therapy.
  • Incidence of grade 3/4 treatment-related adverse events (lung/cardiac/kidney) following InO initiation in all patients [ Time Frame: Through study completion, an average of 1 year ]
    Record grade 3/4 treatment-related adverse events (lung/cardiac/kidney) in all patients following InO initiation
  • Incidence of liver dysfunction following InO initiation in all patients [ Time Frame: Through study completion, an average of 1 year ]
    Record occurrence of liver safety events including VOD/SOS in all patient following InO initiation.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2020