BrigaPED
Research type
Research Study
Full title
A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors Study ITCC-098
IRAS ID
1006345
Contact name
Amos Burke
Contact email
Sponsor organisation
Princess Maxima Center for Pediatric Oncology in The Netherlands
Eudract number
2021-002713-34
Clinicaltrials.gov Identifier
Research summary
Participants diagnosed with blood cancer specifically called anaplastic large cell lymphoma (abbreviated to ALCL) or an inflammatory myofibroblastic tumour (abbreviated to IMT) that can appear in inner (mucosal) surfaces of eyes, nose, mouth etc. or another tumour as neuroblastomas (cancer in some nerve cells) with an irregularity of the ALK gene are invited to participate in the study. Brigatinib is the investigational medicine (study drug) being tested in this study.
The purpose of this study is to find the dosage of brigatinib (study drug), and to test its efficacy in children, adolescents and young adults. Currently there are no effective treatments other than chemotherapy with possible stem cell transplantation for these type of tumours. Laboratory studies and studies in adults with tumours with a change in ALK gene shows strong evidence that brigatinib may help inhibit tumour growth and is itself not chemotherapy which has its own side effects.
In this study, we will evaluate whether the tumour shrinks after administration of brigatinib which will increase the chance to have successful surgery, with less damage and a better chance to remove tumour completely.
Approximately 65 participants, from the ages 1 to 26 years will take part in this research study. This study will be conducted across 16 countries in Europe.
The study comprises of screening period, approximately two years treatment period, followed by a 3 years follow-up period. So, in total, participants will be in this study for approximately 8.5 years.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0291
Date of REC Opinion
6 Oct 2023
REC opinion
Further Information Favourable Opinion