Observational Study of Blinatumomab

Amgen279 enrolled

Overview

An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.

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.

Study Type

OBSERVATIONAL

Enrollment

279

Conditions

Blincyto Use in Routine Clinical Practice

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (80)

Outcomes

Primary Outcomes

Proportion of patients with specified AEs as mentioned in description

* Neurological adverse events * Opportunistic infections * Cytokine release syndrome

Time frame: Estimated to be 100 days

Time to onset of first specified AEs

Time to onset of first specified AEs.

Time frame: 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

Time frame: 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.

Time frame: Estimated to be 100 days

Secondary Outcomes

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.

Time frame: Estimated to be 100 days

Proportion of patients achieving Complete Remission overall and amongst patient sub-groups

Data from ClinicalTrials.gov

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Ordensklinikum Linz Elisabethinen

Linz, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

Hanuschkrankenhaus

Vienna, Austria

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Plzen

Pilsen, Czechia

Ustav hematologie a krevni transfuze

Prague, Czechia

Helsinki University Central Hospital

Helsinki, Finland

Centre Hospitalier Universitaire Dieu Angers

Angers, France

Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

Besançon, France

Hopital d Instruction des Armee

Clamart, France

...and 70 more locations

* 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Estimated to be 100 days

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

Treatment changes include interruption, discontinuation, and dose reduction.

Time frame: 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.

Time frame: Estimated to be 100 days

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