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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44870
• EU PAS number:
  EUPAS41675
• Study ID:
  44870
• Official title and acronym:
  Clinical Systematic Literature Review (SLR) of Ph(-) B-ALL in High-risk First Relapse Paediatric Patients
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will conduct an SLR of evidence from clinical studies to assess the clinical effectiveness of treatments administered for paediatric populations (28 days - 18 years of age) with high-risk first relapse Philadelphia chromosome-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL). The review will include studies with participants in first relapse to first line treatment who were treated with any active anti-tumour treatment, including chemotherapy and Chimeric Antigen Receptor T-cell (CAR-T) therapy. The study designs eligible for inclusion in humans are: Controlled clinical trials, Observational real-world, and, single-arm studies. Electronic databases and congresses will be searched for evidence in line with NICE Health Technology Assessment (HTA) guidance. The process for study selection will be aligned with the 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for the reporting of SLRs and meta-analyses.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 09/10/2020

Actual: 09/10/2020

Study start date

Planned: 27/11/2020

Actual: 27/11/2020

Data analysis start date

Planned: 21/01/2021

Actual: 21/01/2021

Date of interim report, if expected

Planned: 26/02/2021

Actual: 26/02/2021

Date of final study report

Planned: 13/04/2021

Actual: 12/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original Blinatumomab 20200443

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable