RecruitingPHASE4INTERVENTIONAL

Asciminib Roll-over Study

The 'Asciminib Roll-over Study' is for individuals living with a type of blood cancer called Chronic Myelogenous Leukemia (CML) who have previously taken part in another study sponsored by Novartis. If their doctor believes they are still benefiting from asciminib or similar treatments (such as imatinib, nilotinib, or bosutinib) and cannot get it outside of a study, this new study lets them continue receiving the medication. It's designed to gather more information on the long-term safety of these treatments. This is a special type of study that ensures ongoing care for patients who are doing well on a study drug.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Novartis Pharmaceuticals

Enrolment target

347

Start

30 Aug 2022

Estimated completion

30 Aug 2030

Chronic Myelogenous Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What is this study about?

This study is called the 'Asciminib Roll-over Study' and it's for people who have chronic myeloid leukaemia (CML). CML is a type of cancer that affects the blood and bone marrow. We often mention the company Novartis because they are sponsoring this research.

Imagine you've been in a clinical study for a while, taking a medicine called asciminib (or similar drugs like imatinib, nilotinib, or bosutinib) for your CML, and it's working well for you. But what happens when that first study ends? Sometimes, a medicine might still be in development or not yet widely available in your country. This 'roll-over' study is specifically set up for those situations. It gives patients like you the chance to keep receiving the treatment if your doctor believes it is still helping you and you can't get it anywhere else.

The main goal of this study is to keep a close eye on the long-term safety of asciminib and these other related treatments. By continuing to follow patients who are benefiting, doctors can learn more about how these medicines affect people over a longer period, helping to make future treatments even better and safer for everyone with CML.

Key takeaways

It's for people already in a Novartis CML study.
Allows continued access to asciminib or similar treatments.
Focuses on long-term safety and ongoing care.
Requires doctor's approval that treatment is beneficial.
Regular health check-ups and monitoring will be part of it.

Who may be eligible?

This study is for both men and women, aged between 7 and 100 years old. To be considered, you must already be taking asciminib, imatinib, nilotinib, or bosutinib for your CML within another Novartis-sponsored study. Your doctor needs to agree that continuing this treatment is beneficial for you.

You also need to have followed the rules of your previous study and be willing and able to come for all planned visits and appointments for this new study.

However, you won't be able to join if you've already stopped your treatment in the previous study, or if you still have side effects from your old treatment that haven't cleared up. If the treatment you're currently on is already available and paid for in your country, you wouldn't need to join this study. Pregnant or breastfeeding women cannot take part. Additionally, women who could become pregnant must use very effective birth control during the study, and men must follow specific birth control rules if they are on certain medications.

Quick self-check

Are you currently receiving asciminib or similar drugs in a Novartis CML study?
Does your doctor think you are still benefiting from this treatment?
Are you able and willing to attend all study visits?
Are you a pregnant or breastfeeding woman?
Are you aged between 7 and 100 years old?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue to receive the study medication (asciminib or one of the other mentioned drugs) as prescribed. This study focuses on tracking your health over a long period. This means you will need to attend regular clinic visits where the study team will carry out health checks, take blood samples, and ask you questions about how you are feeling and any side effects you might be having. These assessments are important to monitor your progress and ensure the treatment remains safe and effective for you. The total duration of your participation will depend on your individual response to the treatment and your doctor's assessment, but the study is designed for long-term follow-up.

Potential risks and benefits

The main benefit of joining this study is that you can continue receiving a treatment that your doctor believes is helping your CML, especially if it's not available to you outside of a study. This offers ongoing care and a chance to maintain your health. As with all medications, there's always a risk of side effects, and these will be carefully monitored throughout the study. The medical team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (84)

Michigan Med University of Michigan
Ann Arbor, United States· Recruiting
Memorial Sloan Kettering
New York, United States· Recruiting
Oregon Health Sciences University
Portland, United States· Active not recruiting
Texas Oncology
Dallas, United States· Recruiting
Uni Of TX MD Anderson Cancer Cntr
Houston, United States· Recruiting
Novartis Investigative Site
CABA, Argentina· Recruiting
Novartis Investigative Site
Capital Federal, Argentina· Recruiting
Novartis Investigative Site
Graz, Austria· Recruiting
Novartis Investigative Site
Vienna, Austria· Recruiting
Novartis Investigative Site
Rio de Janeiro, Brazil· Completed
Novartis Investigative Site
São Paulo, Brazil· Completed
Novartis Investigative Site
São Paulo, Brazil· Completed

+72 more sites — see the official record for the full list.

Common questions

What is CML?

CML stands for Chronic Myelogenous Leukemia, which is a type of cancer affecting the blood and bone marrow.

Who is sponsoring this study?

This study is sponsored by a pharmaceutical company called Novartis.

What is a 'roll-over' study?

A 'roll-over' study allows patients who have been doing well on a treatment in a previous study to continue receiving that treatment.

Will I take a new medicine in this study?

No, you will continue with the same asciminib or similar medication you were taking in your previous Novartis study.

What is the main reason for this study?

The main reason is to provide continued treatment for patients who are benefiting and to gather more information about the long-term safety of the drugs.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.