Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Multicenter, Open-Label, Single Arm, Phase II Exploratory Study to Evaluate the Reinduction and second stop of TKI with Ponatinib in CML in Molecular Response (ResToP)

This study is for people in the UK who have Chronic Myeloid Leukaemia (CML), a type of blood cancer. Participants have been taking a medication called Iclusig (ponatinib) and their cancer is well-controlled. The study wants to see if, after restarting Iclusig for a period, it's possible for patients to safely stop taking it again. Researchers will be carefully checking to see how many people stay in remission (meaning their cancer is still well-controlled) for at least a year after they stop the Iclusig. They will also be looking at any side effects and how long people remain well without needing treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion Cris De Investigacion Para Vencer El Cancer

Enrolment target

Start

21 Dec 2023

Chronic myelogenous leukemia

What is this study about?

This study is looking at a type of blood cancer called Chronic Myeloid Leukaemia, or CML. People with CML often take a medication called ponatinib, known by its brand name Iclusig, to control their cancer. This particular study is for people who have taken Iclusig for a while, perhaps stopped it once before, and are now taking it again because they needed to.

The main goal of this research is to see if these patients can safely stop taking Iclusig a second time. The doctors will be closely monitoring how many of them remain in a good state of remission, where their cancer is very well controlled, for at least a year after stopping the medication. They will also be checking for any side effects and how long people stay healthy without needing further treatment for their CML.

This is a 'Phase II exploratory study,' which means it's an early stage of clinical research. It aims to gather more information about how this approach works and whether it should be studied in larger groups of people in the future. The results could help doctors understand more about how CML patients can manage their condition and potentially spend more time off medication.

Key takeaways

The study is for adults with a type of blood cancer called CML.
It's about seeing if patients can safely stop the CML drug Iclusig for a second time.
Researchers will check how long people stay well without treatment.
It's an early-stage study to gather more information.
Close monitoring for side effects is a key part of the study.
Participants must be currently taking Iclusig and have good cancer control.

Who may be eligible?

To join this study, you must be an adult, aged 18 or older. Gender doesn't matter, so it's open to both men and women.

Crucially, you must have Chronic Myeloid Leukaemia (CML) and have been taking the medication Iclusig (ponatinib) regularly.

There will be other detailed medical checks to make sure the study is a good fit for you and that it's safe for you to take part. Your doctor will discuss all of these 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 Chronic Myeloid Leukaemia (CML)?
Are you currently taking the medication Iclusig (ponatinib)?
Has your CML been well-controlled on Iclusig for a period?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, Iclusig, as film-coated tablets. The study is particularly interested in what happens after you stop taking Iclusig again. You would have regular check-ups with the study team, which would include blood tests and other assessments. These appointments would track how well your CML is controlled and monitor for any side effects.

These check-ups would happen over a period of at least 52 weeks (one year) after you stop taking Iclusig. The exact number of visits and tests would be explained to you by the study team. The overall duration of your involvement could be longer if you continue to be monitored.

Potential risks and benefits

Potential benefits from taking part might include careful monitoring of your CML and potentially being able to stop medication again, which could improve your quality of life. However, there are also potential risks involved with any medication and stopping treatment. Doctors will be closely watching for any side effects, including blood clot-related issues, bleeding, blood problems, and gut issues. Please remember that participation is voluntary. 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
Spain

Common questions

What is CML?

CML stands for Chronic Myeloid Leukaemia. It's a slow-growing type of blood cancer that starts in the bone marrow, where new blood cells are made.

What is Iclusig (ponatinib)?

Iclusig is a medication used to treat CML. It works by targeting specific proteins to stop cancer cells from growing.

What does 'remission' mean?

In CML, 'remission' means that tests show a very low or undetectable level of the cancer in your body. It means the treatment is working well.

Why would someone stop Iclusig?

If your CML is very well controlled for a long time, doctors sometimes explore whether it's safe to stop treatment to reduce side effects and improve quality of life. This study is looking at doing this for a second time.

Will I have to pay to be in the study?

No, you will not have to pay for the study medication or the extra tests and appointments related to the study.