Healthcare Providers’ Awareness of the risks and safe use conditions associated with BLINCYTO®: A REMS Assessment Survey (20170108)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Philadelphia chromosome negative

  Precursor B-lymphoblastic lymphoma refractory

  B-cell type acute leukaemia

Population studied

• Short description of the study population:
  Healthcare Providers’ (HCPs) who have prescribed, dispensed, prepared and/or administered BLINCYTO in the US in the past 12 months outside the clinical trial setting.; Inclusion criteria includeed HCPs, defined as prescribers [MDs, DOs, Physician Assistants (PAs), Nurse Practitioners (NPs)], nurses (RNs, BSNs), and hospital and/or home healthcare pharmacists who have prescribed, dispensed, prepared and/or administered BLINCYTO therapy to patients outside of the clinical trial setting in the past 12 months.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  To determine the level of awareness on the risks and safe use conditions associated with BLINCYTO therapy and certain aspects of the BLINCYTO REMS Program among healthcare providers (HCPs) who have used BLINCYTO for patients in the treatment of B-cell precursor acute lymphoblastic leukemia (ALL)
• Outcomes:
  • HCP is aware of the risk of cytokine release syndrome associated with use of BLINCYTO• HCP is aware of the risk of neurologic toxicity associated with use of BLINCYTO • HCP is aware of the risk of preparation and administration errors associated with use of BLINCYTO, HCP is aware of the indication for BLINCYTO
• Data analysis plan:
  In general, analyses will be performed for prescribers, nurses, and pharmacists separately, as well as for the pooled group of HCPs to assess the effectiveness of the entire REMS communication plan of BLINCYTO. Demographics and other characteristics of the HCPs will be summarized using proportions. For each survey question, the proportion and 95% CI of each response option including ‘not sure’ will be reported. For each knowledge question, the proportion of HCPs selecting the correct response and corresponding 95% confidence interval will be calculated.

Documents

Study results

20190092 (20170108) csr-20190092-results abstract_public-redacted-approved