CABL001L12101: Paediatric ALL study with ABL
Research type
Research Study
Full title
A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by asciminib plus blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Philadelphia positive, Ph+) or BCR::ABL1-like (Ph-like) acute lymphoblastic leukemia (ALL)
IRAS ID
1011263
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK limited
Research summary
The purpose of this trial is to learn more about the effects of ABL001 with chemotherapy followed by ABL001 with blinatumomab, in children and young adults with acute lymphoblastic leukaemia (ALL) and to find out the best dose of ABL001 for further testing.
ALL is a type of cancer of blood and bone marrow. In ALL, the bone marrow makes too many immature white blood cells too fast, (B-cells [lymphoblasts]), which do not function properly and crowd out healthy blood cells leading to feeling tired, frequent infections, anaemia, and easy bruising or bleeding.
This trial will consist of 2 parts: Parts 1 and 2. Part 1 will test ABL001 with chemotherapy for 1 cycle (4 weeks) followed by ABL001 with blinatumomab for 2 cycles (each lasting 6 weeks). Participants in the first group will take the lowest dose of ABL001. After the dose is considered safe, the next group will take the higher dose level. This is continued until researchers find the chosen dose of ABL001 for further testing in Part 2. In Part 2, participants will take the chosen dose of ABL001 with chemotherapy followed by the chosen dose of ABL001 with blinatumomab.
The goal is to have no ALL cells detected in the body. After 3 cycles, participants and their doctors will determine the next treatment to keep the ALL under control, which will not be part of this trial or covered by Novartis. After this course of treatment, participants have the option to continue treatment with ABL001 for 2 years.
After treatment, participants will be contacted by phone 30 days after receiving the last dose of ABL001 and then every 12 weeks to check their health for a maximum of 3 years.
Approximately 40 participants aged 1 to 30 years are expected to join this trial.REC name
London - Hampstead Research Ethics Committee
REC reference
26/LO/0016
Date of REC Opinion
20 Feb 2026
REC opinion
Further Information Favourable Opinion