Clinical Systematic Literature Review (SLR) of Ph(-) B-ALL in High-risk First Relapse Paediatric Patients

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Medical condition to be studied:
  Philadelphia chromosome negative

Population studied

• Short description of the study population:
  The review will include studies assessing paediatric populations (< 18 years of age) with high-risk Philadelphia chromosome-negative B-precursor ALL in first relapse to first line treatment. Some studies may have used MRD to identify/define relapse/response and will also be included when different definitions used. Studies will be excluded if patients do not have B-precursor ALL, in case of clinically relevant CNS requiring treatment or evidence of current CNS involvement by ALL or if studies report 2nd relapsed patient populations. If a study included patients with clinically relevant CNS involvement as well as those without, and this study separately reports the results for each category of patients, then this study will be included and information for the patients without clinically relevant CNS involvement will be extracted if the other inclusion criteria are met.
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To conduct a SLR of evidence from clinical studies (controlled and observational) to assess the clinical effectiveness of treatments administered for paediatric populations (> 28 days and <18 years of age) with high-risk first relapse Philadelphia chromosome-negative B-ALL
• Data analysis plan:
  Identified evidence will be extracted into an Excel workbook and a qualitative synthesis developed in Word. Tabulated summaries of the studies will be provided to allow the review of the evidence available for the clinical effectiveness and safety of treatments administered for paediatric populations (>28 days and <18 years of age) with high-risk first relapse Philadelphia chromosome-negative B-ALL, categorized by population, intervention, outcome type, and quality. The risk of bias in each included study will be assessed. Bias refers to a process at any stage of inference tending to produce results that depart from the true values. For quality assessment of clinical effectiveness studies (ie, randomised controlled trials RCTs, observational studies and single-arm studies), the Cochrane Collaboration’s tool for assessing risk of bias will be used.

Documents

Study results

Paediatric ALL clinical SLR report_AMSR008_Final report_Executive Summary__12 April 2021