Blinatumomab in infant ALL ,Version 2.0

• Research type

  Research Study

• Full title

  A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-earranged acute lymphoblastic leukemia A collaborative study of the Interfant network

• IRAS ID

  255582

• Contact name

  Philip Ancliff

• Contact email

  philip.ancliff@gosh.nhs.uk

• Sponsor organisation

  Princess Máxima Center for pediatric oncology

• Eudract number

  2016-004674-17

• Clinicaltrials.gov Identifier

  NL5993 (NTR6359), In Netherlands, NTR is the primary registry. Upon registration, an ID is assingned as a registration number.The registration number is equivalent to the NCT number of ClinicalTrials.gov

• Duration of Study in the UK

  2 years, 5 months, 1 days

• Research summary

  The purpose of this study is to investigate whether the drug blinatumomab can safely be added to standard treatment in children with medium or high risk ALL, who have been diagnosed in the first year of life. This study will also investigate the efficacy of blinatumomab.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  21/EM/0065

• Date of REC Opinion

  12 Apr 2021

• REC opinion

  Further Information Favourable Opinion