NCT Number: NCT03117621
Observational Study of Blinatumomab
An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Ordensklinikum Linz Elisabethinen, Linz, Austria
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Proportion of patients with specified AEs as mentioned in description
Time frame: Estimated to be 100 days
- Neurological adverse events
- Opportunistic infections
- Cytokine release syndrome
-
Time to onset of first specified AEs
Time frame: Estimated to be 100 days
Time to onset of first specified AEs.
-
Summary of duration of specified AEs as detailed in the description (all events and resolved/recovered events)
Time frame: Estimated to be 100 days
Summary of duration of specified AEs (all events and resolved/recovered events)
- Neurological adverse events
- Opportunistic Infections
-
Proportion of Blincyto administrations with medication errors
Time frame: Estimated to be 100 days
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.
Secondary outcomes
-
Proportion of patients with AEs as detailed in the description
Time frame: Estimated to be 100 days
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.
-
Proportion of patients achieving Complete Remission overall and amongst patient sub-groups
Time frame: Estimated to be 100 days
- 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.
-
Proportion of patients achieving CR/CRh*/CRi amongst patient sub-groups
Time frame: Estimated to be 100 days
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.
-
Proportion of patients receiving allogeneic HSCT amongst patient sub-groups
Time frame: Estimated to be 100 days
Proportion of patients receiving allogeneic HSCT amongst patient sub-groups. Defined for the subset of subjects who achieved CR.
-
1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups
Time frame: Estimated to be 100 days
1-year and 100-day mortality proportion after allogeneic HSCT amongst patient sub-groups. Defined for the subset of subjects who achieved CR.
-
Relapse-free survival (RFS) time amongst patient sub-groups
Time frame: Estimated to be 100 days
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.
-
Disease Free Survival (DFS) time
Time frame: Estimated to be 100 days
Disease Free Survival time - Defined as time from initiation of Blincyto (for MRD positive patients at initiation) until date of relapse or death.
-
Overall survival (OS) time amongst patient sub-groups
Time frame: Estimated to be 100 days
Overall survival (OS) time - defined as time from initiation of Blincyto until death.
-
Proportion of patients with MRD achieving CR/CRh*/CRi within 2 cycles of Blincyto
Time frame: Estimated to be 100 days
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.
-
Blincyto utilisation: Number of completed cycles
Time frame: Estimated to be 100 days
-
Blincyto utilisation: Total number of days of administration
Time frame: Estimated to be 100 days
-
Blincyto utilisation: Proportion of patients with dose step-up on Day 8
Time frame: Day 8
-
Blincyto utilisation: Number of cycles initiated
Time frame: Estimated to be 100 days
-
Blincyto utilisation: Number of bag changes
Time frame: Estimated to be 100 days
-
Blincyto utilisation: Proportion of patients with treatment changes
Time frame: Estimated to be 100 days
Treatment changes include interruption, discontinuation, and dose reduction.
-
Select healthcare resource use: Number of bag changes in each setting
Time frame: Estimated to be 100 days
Setting of blincyto bag changes include in the hospital, in the outpatient clinic, or at home.
-
Select healthcare resource use: Total number of days of inpatient Blincyto treatment
Time frame: Estimated to be 100 days
-
Select healthcare resource use: Proportion of treatment days that were inpatient
Time frame: Estimated to be 100 days
-
Select healthcare resource use: Incidence of hospitalization not related to infusion
Time frame: Estimated to be 100 days
-
Select healthcare resource use: Length of hospital stay not related to infusion
Time frame: Estimated to be 100 days
Sponsors and collaborators
Lead sponsor
Amgen
Industry
Registry information
Official study title
An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices
Important dates
- Study start
- 2017
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Apr 18, 2017
- Registry last updated
- Apr 4, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.