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Observational Study of Blinatumomab

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ClinicalTrials.gov Identifier: NCT03117621
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease
Blincyto Use in Routine Clinical Practice

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : March 21, 2024
Estimated Study Completion Date : March 21, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Patients initiating Blinatumomab
Patients initiating Blinatumomab after Country-Specific Reimbursement approval in routine clinical practice.



Primary Outcome Measures :
  1. Proportion of patients with specified AEs as mentioned in description [ Time Frame: Estimated to be 100 days ]
    • Neurological adverse events
    • Opportunistic Infections
    • Infusion reactions, including cytokine release syndrome
    • Tumour lysis syndrome
    • Capillary leak syndrome
    • Elevated liver enzymes
    • Febrile neutropenia and neutropenia
    • Decreased immunoglobulin
    • Leukoencephalopathy (including PML)
    • Thromboembolic events (including DIC)
    • Immunogenicity (suspected with antibody test outcome)
    • Worsening of hepatic impairment in patients with hepatic impairment.

  2. Time to onset of first specified AEs [ Time Frame: Estimated to be 100 days ]
    Time to onset of first specified AEs.

  3. 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) Specified AEs

    • Neurological adverse events
    • Opportunistic Infections
    • Infusion reactions, including cytokine release syndrome
    • Tumour lysis syndrome
    • Capillary leak syndrome
    • Elevated liver enzymes
    • Febrile neutropenia and neutropenia
    • Decreased immunoglobulin
    • Leukoencephalopathy (including PML)
    • Thromboembolic events (including DIC)
    • Immunogenicity (suspected with antibody test outcome)
    • Worsening of hepatic impairment in patients with hepatic impairment.

  4. 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 Outcome Measures :
  1. 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.


  2. 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.

  3. Proportion of patients achieving CR/CRh*/CRi overall and 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.

  4. Proportion of patients receiving allogeneic HSCT overall and amongst patient sub-groups [ Time Frame: Estimated to be 100 days ]
    Proportion of patients receiving allogeneic HSCT overall and amongst patient sub-groups. Defined for the subset of subjects who achieved CR.

  5. 1-year and 100-day mortality proportion after allogeneic HSCT overall and amongst patient sub-groups [ Time Frame: Estimated to be 100 days ]
    1-year and 100-day mortality proportion after allogeneic HSCT overall and amongst patient sub-groups. Defined for the subset of subjects who achieved CR.

  6. Relapse-free survival (RFS) time overall and 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.

  7. 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.

  8. Overall survival (OS) time overall and amongst patient sub-groups [ Time Frame: Estimated to be 100 days ]
    Overall survival (OS) time - defined as time from initiation of Blincyto until death.

  9. 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.


  10. Blincyto utilisation: Number of completed cycles [ Time Frame: Estimated to be 100 days ]
  11. Blincyto utilisation: Total number of days of administration [ Time Frame: Estimated to be 100 days ]
  12. Blincyto utilisation: Proportion of patients with dose step-up on Day 8 [ Time Frame: Day 8 ]
  13. Blincyto utilisation: Number of cycles initiated [ Time Frame: Estimated to be 100 days ]
  14. Blincyto utilisation: Number of bag changes [ Time Frame: Estimated to be 100 days ]
  15. Blincyto utilisation: Proportion of patients with treatment changes [ Time Frame: Estimated to be 100 days ]
    Treatment changes include interruption, discontinuation, and dose reduction.

  16. 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.

  17. Select healthcare resource use: Total number of days of inpatient Blincyto treatment [ Time Frame: Estimated to be 100 days ]
  18. Select healthcare resource use: Proportion of treatment days that were inpatient [ Time Frame: Estimated to be 100 days ]
  19. Select healthcare resource use: Incidence of hospitalization not related to infusion [ Time Frame: Estimated to be 100 days ]
  20. Select healthcare resource use: Length of hospital stay not related to infusion [ Time Frame: Estimated to be 100 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include patients receiving Blincyto at participating clinical centres after country-specific reimbursement of Blincyto in the Europe.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117621


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
Show Show 75 study locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03117621    
Other Study ID Numbers: 20150136
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Blincyto