Study identification

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
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc. medinfo@amgen.com

Study contact
medinfo@amgen.com

Global Development Leader Amgen Inc.

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable