Study identification

EU PAS number

EUPAS46562

Study ID

47638

Official title and acronym

An Observational, Ambispective Cohort Study Evaluating the Long-term Effectiveness and Safety of Dinutuximab Beta or Conventional Treatment as Maintenance Therapy in Patients With High Risk Neuroblastoma

DARWIN EU® study

No

Study countries

China

Study description

The aim of this study is to evaluate the long term effectiveness and safety of dinutuximab beta or conventional treatment as first-line maintenance therapy in participants with high risk neuroblastoma

Study status

Ongoing
Research institutions and networks

Institutions

BeiGene
First published:
01/02/2024
Institution
Beijing Children Hospital, Capital Medical University China, Children's Hospital affiliated to Capital Institute of Pediatrics China, Tianjin Cancer Hospital China, Guangzhou Women and Children's Medical Center China, The Children’s Hospital of Fudan University China, Children’s Hospital of Nanjing Medical University China, Shenzhen Children's Hospital China, Hunan Provincial People's Hospital China, Shandong Cancer Hospital China, The Children's Hospital of Zhejiang University School of Medicine China

Contact details

Clinical Trials BeiGene

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:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

BeiGene (Beijing) Co, Ltd
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 1 (imposed as condition of marketing authorisation)

Regulatory procedure number

DINUTUXIMAB BETA EU RMP,NMPA RMP in Chinese