Observational Study of Blinatumomab

Study Overview
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Brief Summary
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An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.

Detailed Description
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The primary objective of this study is to characterize the safety of Blincyto in routine clinical practice. Blincyto effectiveness, medication errors, and utilisation; and select healthcare resource use while using Blincyto will also be described. Safety and effectiveness of Blincyto in specified subgroups of patients will also be assessed.

Official Title
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An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices

Conditions
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Blincyto Use in Routine Clinical Practice

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Medical records of patients initiating Blincyto after country-specific reimbursement in routine clinical practice will be eligible for extraction. Exclusion Criteria: Medical records of patients who have participated in Blincyto clinical trials will be excluded since their treatment will be prescribed by the study protocol unless the patient is receiving new Blincyto treatment outside the clinical trial. Medical records of patients participating in other Amgen non-interventional prospective studies in which safety endpoints are collected will be excluded. Medical records of patients who have received Blincyto via an expanded access/compassionate use program will be excluded. In countries where patient informed consent is required for access to their medical records, any patient who does not provide informed consent will be excluded.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients initiating Blinatumomab<br>Patients initiating Blinatumomab after Country-Specific Reimbursement approval in routine clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with specified AEs as mentioned in description | Neurological adverse events Opportunistic infections Cytokine release syndrome | Estimated to be 100 days | 
| Time to onset of first specified AEs | Time to onset of first specified AEs. | Estimated to be 100 days | 
| Summary of duration of specified AEs as detailed in the description (all events and resolved/recovered events) | Summary of duration of specified AEs (all events and resolved/recovered events) Neurological adverse events Opportunistic Infections | Estimated to be 100 days | 
| Proportion of Blincyto administrations with medication errors | Proportion of Blincyto administrations with medication errors, defined as an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient, identified through medical records. Types of medication errors will also be described incorrect Blincyto dose administered/prepared (eg. drug concentration, device issues, treatment according to SmPC) does not include treatment related to dexamethasone. | Estimated to be 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with AEs as detailed in the description | Incidence of all AEs collected in this study (overall, and by severity and seriousness) occurring during blinatumomab treatment and up to 30 days after completion of treatment • Incidence of specified AEs and all AEs collected in this study among patient subgroups defined by demographic and clinical factors. | Estimated to be 100 days | 
| Proportion of patients achieving Complete Remission overall and amongst patient sub-groups | Proportion of patients achieving Complete Remission within 2 cycles of Blincyto treatment Complete remission - Defined as ≤ 5% bone marrow myeloblasts, platelets more than 100,000 cells per µL, and absolute neutrophil count > 1,000 cells per µL. | Estimated to be 100 days | 
| Proportion of patients achieving CR/CRh*/CRi amongst patient sub-groups | Proportion of patients achieving CR/CRh*/CRi within 2 cycles Blincyto treatment CR defined as ≤ 5% bone marrow blasts, platelets more than 100,000 cells per µL, and absolute neutrophil count > 1,000 cells per µL CRh* defined as ≤ 5% bone marrow blasts, platelets more than 50,000 cells per µL, and absolute neutrophil count > 500 cells per µL CRi defined as ≤ 5% bone marrow blasts and incomplete recovery of peripheral blood counts. | Estimated to be 100 days | 
| Proportion of patients receiving allogeneic HSCT amongst patient sub-groups | Proportion of patients receiving allogeneic HSCT amongst patient sub-groups. Defined for the subset of subjects who achieved CR. | Estimated to be 100 days | 
| 1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups | 1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups. Defined for the subset of subjects who achieved CR. | Estimated to be 100 days | 
| Relapse-free survival (RFS) time amongst patient sub-groups | Relapse-free survival (RFS) time - defined as time from CR/CRh*/CRi until relapse (proportion of blasts in bone marrow > 5% or blasts in peripheral blood after documented CR/CRh*/CRi) or death. Defined for the subset of subjects who achieved CR. | Estimated to be 100 days | 
| Disease Free Survival (DFS) time | Disease Free Survival time - Defined as time from initiation of Blincyto (for MRD positive patients at initiation) until date of relapse or death. | Estimated to be 100 days | 
| Overall survival (OS) time amongst patient sub-groups | Overall survival (OS) time - defined as time from initiation of Blincyto until death. | Estimated to be 100 days | 
| Proportion of patients with MRD achieving CR/CRh*/CRi within 2 cycles of Blincyto | Overall and amongst patient sub-groups - Proportion of patients with minimal residual disease (MRD) among those who achieve CR/CRh*/CRi within two cycles of Blincyto treatment - hematologic MRD detected by polymerase chain reaction (PCR) (or flow cytometry) at a level of 1 x 10-4 or higher. | Estimated to be 100 days | 
| Blincyto utilisation: Number of completed cycles |  | Estimated to be 100 days | 
| Blincyto utilisation: Total number of days of administration |  | Estimated to be 100 days | 
| Blincyto utilisation: Proportion of patients with dose step-up on Day 8 |  | Day 8 | 
| Blincyto utilisation: Number of cycles initiated |  | Estimated to be 100 days | 
| Blincyto utilisation: Number of bag changes |  | Estimated to be 100 days | 
| Blincyto utilisation: Proportion of patients with treatment changes | Treatment changes include interruption, discontinuation, and dose reduction. | Estimated to be 100 days | 
| Select healthcare resource use: Number of bag changes in each setting | Setting of blincyto bag changes include in the hospital, in the outpatient clinic, or at home. | Estimated to be 100 days | 
| Select healthcare resource use: Total number of days of inpatient Blincyto treatment |  | Estimated to be 100 days | 
| Select healthcare resource use: Proportion of treatment days that were inpatient |  | Estimated to be 100 days | 
| Select healthcare resource use: Incidence of hospitalization not related to infusion |  | Estimated to be 100 days | 
| Select healthcare resource use: Length of hospital stay not related to infusion |  | Estimated to be 100 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blincyto