All studies
AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

This research study is for children, teenagers, and young adults who have a specific type of blood cancer called Acute Lymphoblastic Leukemia (ALL). This cancer is either Philadelphia chromosome-positive (Ph+) or Ph-like, and it has returned after treatment or didn't respond to previous treatments. The study is testing a new combination of medicines, including asciminib, chemotherapy, and blinatumomab. Doctors want to see how safe this new combination is and how well it works to reduce or get rid of the cancer. This is an early-stage study, meaning researchers are cautiously trying to find the best and safest way to use these treatments together.

At a glance

Status
Authorised
Phase
Phase I and Phase II (Integrated)- Other
Sponsor
Novartis Pharma AG
Enrolment target
21
Start
27 Apr 2026

What is this study about?

This study is investigating a new treatment approach for a type of blood cancer called Acute Lymphoblastic Leukemia, or ALL. Specifically, it's for patients whose ALL has certain genetic features, known as Philadelphia-positive (Ph+) or Ph-like ALL. This means a particular change has happened in their cancer cells. The study is for children, adolescents, and young adults whose cancer has either come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).

The main goal of this study is to find out if giving a new medicine called asciminib, alongside standard chemotherapy, followed by another medicine called blinatumomab, is a safe and effective way to treat this type of ALL. The study is split into two parts: the first part will help doctors find the best and safest dose of the new treatment combination. The second part will then look at how well that chosen dose works to make the cancer go away.

Researchers will be carefully tracking any side effects patients might experience, as well as looking at how many patients see their cancer go into remission (a state where there are no signs of disease). They will also look at how long patients stay free of the disease and how long they live afterwards. This research is important because it could lead to new and better ways to treat ALL for young patients when other treatments haven't worked.

Key takeaways

  • Tests a new combination treatment for specific types of relapsed or refractory ALL.
  • Aims to find safest dose and how well the treatment works.
  • Involves asciminib, chemotherapy, steroids, and blinatumomab.
  • Careful monitoring for side effects and treatment response.
  • For patients aged 18 and over with the specified cancer types.
  • Participation is voluntary and you can withdraw at any time.

Who may be eligible?

This study is for patients aged 18 and older, both male and female, who have a specific type of blood cancer.

The cancer must be Acute Lymphoblastic Leukemia (ALL) that is either Philadelphia chromosome-positive (Ph+) or Ph-like. It's important that your cancer has either come back after previous treatment or has not responded to other treatments you've had.

There will be other detailed medical checks to make sure this study is right and safe for you, which your doctor will discuss. Currently, the age range starts from 18 years, so children and younger teenagers are not eligible for this specific trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have Acute Lymphoblastic Leukemia (ALL)?
  3. Has your ALL been identified as Philadelphia chromosome-positive (Ph+) or Ph-like?
  4. Has your ALL come back after previous treatment, or did it not respond to earlier treatments?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive a combination of medicines including asciminib, chemotherapy drugs (like cytarabine, methotrexate, vincristine sulfate), steroids (like hydrocortisone, prednisolone acetate, dexamethasone), and blinatumomab. These will be given in cycles, meaning you'll have periods of treatment followed by rest periods.

Throughout the study, you'll have regular hospital visits for assessments. These will involve blood tests to check how you're responding to the treatment and to monitor for any side effects. You'll also have scans or other tests to look at the cancer. The first part of the study will involve closely monitoring side effects during the first treatment cycle to find the safest dose. The second part will focus on how many people's cancer goes into remission after the first cycle. The total duration of your participation will depend on how you respond to the treatment and the study’s protocol, but it will involve follow-up appointments after the main treatment period.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive new treatments that aren't yet widely available, which might be more effective for your specific type of cancer. It also helps advance medical knowledge for others. However, there are potential risks, as new treatments can have unexpected side effects. Researchers will closely monitor you for any adverse effects, which will be carefully recorded. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Italy
  • Unverified
    Spain
  • Unverified
    Germany
  • Unverified
    Netherlands
  • Unverified
    France
  • Unverified
    Denmark
  • Unverified
    Czechia

Common questions

What kind of cancer is this study for?

This study is for a specific type of blood cancer called Acute Lymphoblastic Leukemia (ALL) that has particular genetic features (Ph+ or Ph-like) and has either come back or not responded to previous treatments.

What medicines will I be given?

You will receive a combination of medicines, including asciminib, chemotherapy drugs, and steroids, followed by another medicine called blinatumomab.

What is the main goal of this study?

The main goal is to find out if this new combination of medicines is safe and how well it works to reduce or get rid of the cancer in affected children, teenagers, and young adults.

Will I be closely monitored during the study?

Yes, you will have regular hospital visits, blood tests, and other checks to monitor your health and how the treatment is working.

Can I leave the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, and this won't affect your medical care.

How to find out more

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

Discussion

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