AuthorisedTherapeutic exploratory (Phase II)Interventional

CANDIDATE THERAPIES IN COMBINATION OR SEQUENTIALLY WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN COMPLETE CYTOGENETIC RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE: AN ADAPTIVE TRIAL BASED ON A DROP LOSER DESIGN - ACTIW STUDY

This research study, called ACTIW, is for adults with a type of blood cancer called Chronic Myeloid Leukaemia (CML). These patients are currently in a good stage of treatment, but haven't achieved a 'deep molecular response', meaning there's still a very small, but detectable, amount of the CML gene (BCR-ABL1) in their blood. The study is testing whether adding new drugs, Actos or Avelumab, to their current CML medication (Tyrosine Kinase Inhibitors) can help them achieve this deeper remission. The main goal is to see how many people reach a very low level of the CML gene (MR4.5) within 12 months. This could be an important step towards potentially stopping CML treatment in the future.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier De Versailles

Enrolment target

250

Start

16 Sep 2024

CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML)

What is this study about?

This study is called ACTIW, and it's looking into new ways to treat Chronic Myeloid Leukaemia (CML). CML is a type of cancer that affects the blood and bone marrow. For many people with CML, existing treatments, called Tyrosine Kinase Inhibitors (TKIs), work very well to control the disease. However, some people might not reach what doctors call a 'deep molecular response'. This means that while they are doing well and the disease is largely controlled, there's still a very tiny amount of the CML gene (called BCR-ABL1) detectable in their blood.

Doctors believe that reaching this deeper level of remission, known as MR4.5 (which means the CML gene is at an extremely low level, or less than 0.0032%), could be a big step. It might mean that in the future, some people could safely stop taking their CML medication altogether, leading to a better quality of life and avoiding side effects. This study aims to find out if adding new medications on top of their current TKI treatment can help more people achieve this important deep remission.

The study will look at two different extra medicines: Actos tablets or a drug called Avelumab. Both of these will be given alongside a patient's current TKI treatment. Researchers will carefully check how these combinations work, looking at how many people reach the deep remission target within a year, and also monitoring for any side effects. They'll also look at longer-term effects over several years, including whether people can eventually stop treatment and remain in remission.

Key takeaways

This study is for adults with CML who are doing well but haven't reached a 'deep molecular response'.
It tests if adding Actos or Avelumab to current CML treatment can help achieve deeper remission.
A 'deep molecular response' might eventually allow some people to stop CML medication.
Researchers will monitor CML gene levels and side effects closely.
Participation involves regular clinic visits for checks and blood tests.

Who may be eligible?

To join this study, people need to be adults, aged 18 or over. This study is specifically for individuals who have been diagnosed with Chronic Myeloid Leukaemia (CML) and are in what's known as the 'chronic phase'. This means their disease is stable and not in a more advanced or aggressive stage.

Crucially, participants must already be taking standard CML medication (Tyrosine Kinase Inhibitors), and while these drugs are working well to control the cancer, they haven't yet reached a 'deep molecular response'. This means that the CML gene (BCR-ABL1) is still detectable at a certain level, even though it's much lower than it was before treatment.

The study is open to both men and women. There will be other specific medical checks to make sure joining the study is safe and appropriate for each person.

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) in the chronic phase?
Are you currently taking CML medication (a TKI)?
Has your CML been controlled by your TKI, but you haven't reached a 'deep molecular response'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would continue taking your current CML medication (Tyrosine Kinase Inhibitor). In addition, you would either take Actos tablets or receive Avelumab. The study will involve regular visits to the clinic for medical check-ups, blood tests, and to monitor how you're feeling and if the treatment is working. These tests will help doctors track your CML gene levels very closely.

Researchers will also be looking at any side effects you might experience. The primary goal is to see the effect of the new treatment within the first 12 months, but your progress will be followed for a longer period, potentially several years, to see if you maintain the deep remission and if it's possible to consider stopping your CML treatment. The exact number and frequency of visits, as well as the total duration you'd be actively involved in the treatment phase of the study, would be explained in full by the study team.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of achieving a deeper level of remission for your CML, which could eventually open the door to stopping your CML medication. However, like all medicines, the new drugs Actos and Avelumab can have side effects, which the study team will monitor closely. There might also be side effects from taking part in extra tests and procedures. It's important to remember that you can decide to leave 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
France

Common questions

What is CML?

CML (Chronic Myeloid Leukaemia) is a slow-growing cancer of the blood and bone marrow. It's caused by a change in a specific gene called BCR-ABL1.

What does 'deep molecular response' mean?

It means the amount of the CML gene (BCR-ABL1) in your blood has dropped to a very, very low level, almost undetectable. This is a very good sign that your treatment is working well.

What are Tyrosine Kinase Inhibitors (TKIs)?

TKIs are a common type of medicine used to treat CML. They work by blocking the specific protein that helps CML cells grow.

Will I have to stop my current CML medication if I join?

No, you will continue your current CML medication. This study is testing if adding new drugs to your existing treatment can help you achieve a deeper response.

What is the main goal of this study?

The main goal is to see if adding new treatments like Actos or Avelumab to current CML medication can help more people reach a very deep remission within 12 months.