* Rollover trial to assess long term safety in ABL001 treated patients
Research type
Research Study
Full title
An open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
IRAS ID
302693
Contact name
Jane Apperley
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-000602-17
Clinicaltrials.gov Identifier
CANC49809, CPMS ID
Duration of Study in the UK
4 years, 5 months, 20 days
Research summary
Chronic myeloid leukemia (CML) is a type of cancer that starts in certain blood-forming cells of the bone marrow. In the majority of subjects CML occurs when a chromosome translocation results in the production of BCR-ABL protein, a constitutively active Tyrosine Kinase that causes over production of immature blood cells (leukaemia). If untreated, the disease progresses from an initial chronic phase (duration of 3 to 5 years) to an accelerated phase of shorter duration to a fatal blast crisis. Tyrosine Kinase Inhibitors (TKI’s) have revolutionised treatment of CML resulting in overall survival close to normal life expectancy.
The purpose of this study is to assess long-term safety and to provide continued treatment with asciminib for patients with CML-CP who have participated in a Novartis sponsored asciminib clinical study (Parent study) and, in the opinion of the investigator, would benefit from continuing treatment. Patients will also have alternative options available dependent on the Parent study they roll over from (if in the opinion of the investigator they are receiving a clinical benefit):
CABL001E2201 - Participants who completed this study and who were receiving imatinib (either in combination with asciminib or as single agent) or nilotinib (as single agent) can be enrolled in this study.
CABL001A2301- Participants on bosutinib treatment at the end of the study treatment phase, can be enrolled in this study and continue bosutinib. The primary analysis of study A2301 demonstrated superiority of asciminib as compared to bosutinib, therefore participants will be provided an option to switch from bosutinib to asciminib at the start of this study or at any time during the study (if in the opinion of the investigator they will benefit from the switch).
The primary objective is to assess long-term safety (frequency and severity of AE’s and SAE’s).
REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0249
Date of REC Opinion
28 Oct 2021
REC opinion
Favourable Opinion