Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Ponatinib for the management of minimal residual disease (MRD) and hematologic relapsein adult Ph+ acute lymphoblastic leukemia (Ph+ ALL) patients.ALL2620

This research study, called ALL2620, is for adults aged 18 and over who have a specific type of blood cancer called Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). The main goal is to find out how effective a drug called ponatinib is at reducing very small amounts of leukaemia cells that might still be present after initial treatment, or if the leukaemia has returned. Researchers will examine this after three months of treatment. Some patients might receive ponatinib on its own, while others might get it alongside other standard chemotherapy drugs. We also want to understand the safety of the treatments, how long people stay well, and how the leukaemia cells change over time.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Gimema Franco Mandelli Onlus

Enrolment target

Start

18 Sep 2024

Ph+ Acute Lymphoblastic Leukemia

What is this study about?

This study is looking into a medication called ponatinib for adult patients with a specific type of blood cancer. This cancer is known as Philadelphia chromosome-positive acute lymphoblastic leukaemia, often shortened to Ph+ ALL. Sometimes, even after initial treatment, a tiny amount of leukaemia cells can remain in the body, which doctors call 'minimal residual disease' (MRD). Other times, the leukaemia might come back entirely. This study aims to find better ways to manage these situations.

The main purpose of this study is to see how well ponatinib works in reducing these remaining leukaemia cells or helping patients whose leukaemia has returned. Researchers will check this after three months of treatment. For some patients, ponatinib might be given on its own, while for others, it might be combined with other chemotherapy drugs like cytarabine, methotrexate, or vincristine, and sometimes steroids such as methylprednisolone or prednisone.

Beyond just reducing leukaemia cells, the study also wants to understand other important things. This includes looking at how safe the treatment is, how long patients stay free of leukaemia, and how the leukaemia cells might change or develop different features during treatment. All this information will help doctors understand if ponatinib can be a good option for people with Ph+ ALL.

Key takeaways

The study investigates ponatinib for adult Ph+ ALL patients.
It aims to reduce remaining leukaemia cells (MRD) or treat leukaemia that has returned.
Treatment may involve ponatinib alone or with chemotherapy.
Researchers will check how well the treatment works after 3 months.
Safety and long-term effects are also being carefully studied.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. This study is open to both men and women.

You would be eligible if you have Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) and either still have a small amount of leukaemia cells after previous treatment (minimal residual disease) or your leukaemia has returned.

The research team will need to check other health details to make sure this study is right for you and that taking part would be safe. They will discuss all the specific requirements with you.

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 18 years old or older?
Do you have Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL)?
Has your leukaemia shown minimal residual disease (MRD) or returned?
Are you able to attend regular hospital appointments for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, which could be ponatinib on its own or in combination with other chemotherapy drugs like cytarabine, methotrexate, vincristine, and steroids. This treatment will be given over a period of at least three months. You would have regular appointments at the hospital or clinic. These visits will involve blood tests and other assessments to monitor your health, how the treatment is working, and to check for any side effects. The exact number of visits and tests will depend on the specific treatment plan, but the overall aim is to assess your progress after three months of treatment, with ongoing follow-up to understand long-term outcomes like how long you remain well.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment option for your condition, or helping doctors understand more about your type of leukaemia. However, like all medications, ponatinib and the other chemotherapy drugs can cause side effects. The research team will carefully monitor you for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is Ph+ ALL?

It's a specific type of fast-growing blood cancer called acute lymphoblastic leukaemia, where the leukaemia cells have a particular genetic change called the Philadelphia chromosome.

What does 'minimal residual disease' (MRD) mean?

MRD means there are still very small numbers of leukaemia cells in your body after treatment, even if you seem to be in remission.

What is ponatinib?

Ponatinib is a type of targeted drug that works by blocking signals that help leukaemia cells grow.

How long will the treatment last?

The study aims to assess results after at least three months of treatment, but the overall treatment duration will depend on your individual response and plan.

Will I get ponatinib alone or with other drugs?

This will depend on your specific situation and the study arm you are assigned to, as some patients receive ponatinib alone, and others receive it with chemotherapy.