Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase II Study of Dasatinib Therapy in Children and Adolescents with Ph+ Leukemias Resistant or Intolerant to Imatinib.

This research study is looking into a medicine called Dasatinib for children and teenagers who have a specific type of blood cancer, known as Ph+ leukemia. It's particularly for those who are newly diagnosed or whose current treatment, Imatinib, isn't working as well as hoped, or if they have had bad side effects from it. The study wants to see how effective Dasatinib is at reducing the number of cancer cells and improving blood counts. It's an early-stage study to learn more about how the drug works in this group of patients.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

Start

03 May 2024

Children and Adolescents with Newly Diagnosed Chronic Phase CML or with Ph+ Leukemias Resistant to or Intolerant to Imatinib

What is this study about?

This study is designed for children and teenagers who have a type of blood cancer called Philadelphia chromosome-positive (Ph+) leukemia. This is a condition where certain cells in the blood grow abnormally.

Often, the first treatment for this type of leukemia is a medicine called Imatinib. However, sometimes Imatinib might not work as well as doctors hoped, or some patients might have side effects that make it difficult to continue taking it. This study is exploring a different medicine called Dasatinib as a possible option for these situations.

The main goal of the study is to see how well Dasatinib helps to control the leukemia. Doctors will be checking to see if it reduces the amount of cancer in the blood and bone marrow, and if it helps improve a patient's overall blood counts. This is important to help doctors understand if Dasatinib could be a good treatment choice for young patients who need an alternative to Imatinib.

Key takeaways

This study is for children and teenagers with Ph+ leukemia.
It uses a medicine called Dasatinib.
It's for those who can't take or don't respond to Imatinib.
The aim is to see how well Dasatinib works at controlling the cancer.
You'll have regular checks by doctors if you join.
Your health and safety are the top priority.

Who may be eligible?

This study is open to both boys and girls of any age, from young children to teenagers. You might be able to join if you have a specific type of blood cancer called Philadelphia chromosome-positive (Ph+) leukemia.

Importantly, for you to be considered, your leukemia either needs to be newly diagnosed and in its early stage (called chronic phase CML), or if you've already been treated with Imatinib, it must not have worked effectively for you, or you had side effects that stopped you from taking it.

The medical team will carefully check other details about your health to make sure this study is the right and safest option for you. They will explain everything clearly.

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.

Are you a child or teenager?
Do you have Philadelphia chromosome-positive (Ph+) leukemia?
If you've had Imatinib, did it not work well, or did you have bad side effects?
Are you newly diagnosed with chronic phase CML?
Are you able to attend regular hospital visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the medication called Dasatinib. You will have regular visits to the hospital or clinic so the doctors can monitor your health and how the medicine is affecting your leukemia. These visits will likely include blood tests, bone marrow tests, and other checks to see how well the treatment is working and to watch for any side effects. The medical team will tell you exactly how often these visits will be and what they will involve, as well as the total length of time you'll be part of the study.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a different medicine, Dasatinib, if other treatments haven't worked well for you. It could help control your leukemia and improve your health. However, like all medicines, Dasatinib can have side effects, and some might be serious. The medical team will explain all the known risks before you decide to join and will monitor you closely for any issues. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Spain

Common questions

What is Ph+ leukemia?

It's a type of blood cancer where there's a specific change in the chromosomes of your blood cells, causing them to grow abnormally.

What is Dasatinib?

Dasatinib is a type of medicine that targets and blocks certain proteins that help cancer cells grow, helping to control the illness.

Why is this study looking at children and teenagers?

It's important to find the best and safest treatments for young people, as their bodies can react differently to medicines than adults.

Will I still get my usual care if I join?

Yes, you will continue to receive good medical care, and your doctors will closely watch your health throughout the study.

What happens if Dasatinib doesn't work for me?

The medical team will discuss other treatment options available to you if Dasatinib isn't effective or if you can't tolerate it.