AuthorisedTherapeutic exploratory (Phase II)Interventional

A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL

This study is for adult patients diagnosed with T-cell Acute Lymphoblastic Leukaemia (T-ALL), a type of blood cancer, where their previous treatments haven't worked or the cancer has returned. It's an important step in finding better ways to treat this condition. The study is particularly looking at how different combinations of existing medicines, like Venetoclax and others, might be used in a more targeted way to fight the cancer. Researchers want to see if these new approaches can help shrink the cancer or put it into remission. They'll also be closely monitoring how patients feel and any side effects, to make sure treatments are as safe and effective as possible. This is a Phase II study, meaning it’s focused on exploring how well these treatments work.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier De Versailles

Enrolment target

Start

29 May 2026

Relapsed/refractory T-cell Acute Lymphoblastic Leukemia

What is this study about?

This study is looking into a type of blood cancer called T-cell Acute Lymphoblastic Leukaemia (T-ALL). This particular study is for people whose T-ALL has either come back after treatment, or hasn't responded well to previous treatments. The main goal is to find better ways to treat this challenging condition.

The researchers are exploring different combinations of existing medications, such as Venetoclax, Enrylaze, XELJANZ, Azacitidine, and Afinitor. By trying these medicines in new ways, sometimes called 'precision medicine', they hope to find treatments that are more effective and specifically targeted to each patient's cancer. This is a Phase II study, which means it's still in the early stages of testing these new approaches.

The study will carefully track how well these treatments work. This includes looking at whether the cancer goes into remission (meaning signs of cancer are reduced or gone) within three months, and how long that remission lasts. They’ll also be monitoring patients' overall health, any side effects, and their quality of life. This detailed observation helps doctors understand not just if a treatment works, but how it affects patients' daily lives.

Key takeaways

This study is for adults with T-cell Acute Lymphoblastic Leukaemia (T-ALL) that hasn't responded to earlier treatments or has returned.
It aims to find better ways to use existing medicines in combination.
The main goal is to see if these new approaches can put the cancer into remission.
Your health, side effects, and quality of life will be carefully monitored.
Participation involves regular hospital visits and taking study medications.
It's a Phase II study, meaning it's still exploring how well these treatments work.

Who may be eligible?

This study is designed for adult patients who have been diagnosed with T-cell Acute Lymphoblastic Leukaemia (T-ALL). A key requirement is that your leukaemia has either returned after you've already had treatment, or it hasn't responded well to the treatments you've received so far.

There isn't an upper age limit for taking part, so any adult over the age of 18 can be considered. The study is open to both men and women. Your medical team will need to check other specific details about your health and your cancer to make sure this study is the right fit for 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 T-cell Acute Lymphoblastic Leukaemia (T-ALL)?
Has your T-ALL come back after previous treatment?
Has your T-ALL not responded well to earlier treatments?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your journey will involve receiving specific medications as chosen by the study doctors, which may include drugs like Venetoclax, Enrylaze, XELJANZ, Azacitidine, or Afinitor. You'll have regular hospital visits for these treatments and check-ups. During these visits, doctors will closely monitor your health, check for any side effects, and assess how the treatment is working against your leukaemia.

This will involve blood tests, and potentially other procedures to understand the cancer’s response. You will also be asked to complete questionnaires about your quality of life and mood every month for the first three months. The aim is to track your progress and how you are feeling over time. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be closely followed for a certain period even after your treatment ends.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as gaining access to new treatment approaches for your T-ALL that might be more effective than standard options, especially if your leukaemia hasn't responded to previous treatments. However, like all medical treatments, there are potential risks. The medicines used in this study can have side effects, which your medical team will discuss with you in detail and monitor closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Germany
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Unverified
France
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Unverified
Czechia
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Unverified
Netherlands
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Unverified
Spain

Common questions

What type of cancer is this study for?

This study is specifically for T-cell Acute Lymphoblastic Leukaemia (T-ALL) that has returned or not responded to previous treatments.

What medicines are being tested?

The study explores combinations of medicines such as Venetoclax, Enrylaze, XELJANZ, Azacitidine, and Afinitor.

What does 'remission' mean in this study?

Remission means that the signs of your leukaemia are reduced or have disappeared, either completely or almost completely, without full recovery of blood counts.

Will my quality of life be monitored?

Yes, you will complete questionnaires monthly for the first three months to assess your quality of life and mood.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your regular medical care.