This study is for people with chronic myelogenous leukemia (also called CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It is an open-label study, which means the treatment is known to the study team and the participants. The treatment used in the study is asciminib hydrochloride, taken by mouth. The purpose of the study is to check the long-term safety of continuing asciminib after a previous study.
The study follows people who have already completed an earlier asciminib study and are considered by the doctor to still benefit from treatment. Treatment is continued over time, and regular study visits are planned so that health and any side effects can be watched. The study looks at possible adverse events, which are unwanted health problems that happen during treatment, and serious adverse events, which are more severe health problems. In some parts of the study, other tyrosine kinase inhibitors that may have been used in earlier studies include nilotinib, dasatinib, imatinib, and bosutinib.
The study is designed to provide continued access to the same study treatment received before while long-term safety is followed over time.
Who Can Join the Study?
You must have Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The Philadelphia chromosome is a change in the leukemia cells’ chromosomes, which are the structures that carry genes.
You must be currently receiving asciminib, either by itself or together with imatinib, nilotinib, or dasatinib. These are medicines used to treat leukemia.
Or, if you were in the comparator arm of a Novartis-sponsored study, you must be receiving the study treatment that was assigned in that group. A comparator arm is the group used for comparison in a clinical trial.
You must have already met the requirements for the main part of the study and have finished the treatment phase.
The study doctor must think that you would benefit from continuing treatment.
Who Cannot Join the Study?
The person was stopped from treatment in the parent study for any reason.
The person still has severe side effects from the parent study that are thought to be possibly related to the study treatment. Grade 3 or 4 means a serious or very serious side effect. These side effects must not have improved to Grade 2 or lower within the allowed time: 42 days for blood-related side effects, or 28 days for side effects not related to blood.
The person needs to stop study treatment for longer than the allowed time because of ongoing side effects: more than 42 days for hematological toxicities (blood-related side effects) or more than 28 days for non-hematological toxicities (side effects not related to blood).
The person’s current treatment is already approved and paid for at the country level. This means the treatment is already available through normal care in that country.
The person is pregnant.
The person is breastfeeding or nursing.
The person is a woman who can become pregnant and is not using a highly effective method of birth control.
Asciminib is the main study medicine in this trial. It is taken by mouth and is being continued in people who already used it in a previous study and were thought to still benefit from it. The trial is mainly looking at how safe long-term use of this medicine is, including any serious side effects or other unwanted effects over time.
Nilotinib is another oral cancer medicine included in the study group. It is used as an active treatment option for people with certain blood cancers, and the trial includes participants who may have received this medicine before or who are being followed while on it. The study helps monitor how safe it is when used over a longer period.
Dasatinib is an oral treatment used for some types of leukemia. In this trial, it is one of the active medicines that participants may have been receiving in parent studies before rolling over into this long-term safety study. Its role here is to continue treatment and watch for side effects during ongoing use.
Imatinib is an oral medicine used to treat certain blood cancers. It is included as an active treatment option in the study for participants who were already taking it in earlier studies. The trial follows patients who stay on this medicine to better understand its long-term safety and tolerability.
Bosutinib is an oral cancer medicine that may be used in people with certain leukemia types. It appears in the study as another active treatment that participants may continue from a previous trial. The study is not testing whether it works better, but rather tracking safety while treatment continues over time.
Chronic myelogenous leukemia – A cancer of the blood and bone marrow that begins with too many immature white blood cells. It usually develops slowly at first, then can progress through a more active phase and, in some cases, to a more advanced phase with faster growth of abnormal cells. The disease may cause the bone marrow to make fewer normal blood cells over time. Philadelphia chromosome-positive acute lymphoblastic leukemia – A fast-growing cancer of the blood and bone marrow that starts from very early lymphoid cells. It develops quickly as abnormal cells build up and crowd out normal blood cells. The disease can worsen as these immature cells continue to multiply and spread within the marrow and blood.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Austria 
Bulgaria 
Czechia 
Denmark 
France 
Germany 
Greece 
Hungary 
Italy 
Poland 
Portugal 
Romania 
Slovakia 
Spain 