ASC4START

• Research type

  Research Study

• Full title

  A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

• IRAS ID

  1005761

• Contact name

  Iris Hitzler

• Contact email

  iris.hitzler@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2022-000995-21

• Clinicaltrials.gov Identifier

  NCT05456191.

• Research summary

  The purpose of the study is to investigate the tolerability of asciminib compared to nilotinib for treating newly diagnosed patients with Philadelphia Chromosome Positive chronic myeloid leukemia in chronic phase (CML-CP). CML is characterised by an abnormal chromosome called the "Philadelphia chromosome.” The Philadelphia chromosome creates an abnormal protein (BCR::ABL1) that causes some cancerous white blood cells (leukemia cells) to grow.

  Asciminib has been approved in the US, Japan and other countries to treat people with CML-CP who have previously been treated with 2 or more medicines and is now being evaluated as a first treatment for patients with CML-CP. Nilotinib is a medicinal treatment allowed by the MHRA for newly diagnosed patients with CML-CP.

  Approximately 541 participants with CML-CP aged 18 years and older will join this study from more than 20 countries.
  Participants may receive asciminib or nilotinib as study treatment. There will be an equal chance of being given either asciminib or nilotinib.

  Participants will be asked to come to the hospital every 2 weeks for the first month, then every 3 months. The length of study treatment will depend on the date of enrolment in the study and on when a defined number of certain events is reached. The treatment length is expected to be approximately 2 to 4.5 years. During that time, participants may need to visit the hsopital up to approximately 23 times. Most study visits should take about 2-3 hours. However, the first visit may be longer, about 3-4 hours.

  At the study visits, the following type of procedures may happen:
  Clinical assessments, Physical examinations, Blood tests, Bone Marrow aspiration (if needed).

  Participants will be asked to take 2 tablets of asciminib by mouth once a day, under fasting conditions or 2 capsules of nilotinib by mouth twice a day, under fasting conditions.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  22/EM/0257

• Date of REC Opinion

  9 May 2023

• REC opinion

  Further Information Favourable Opinion