RecruitingPHASE2, PHASE3INTERVENTIONAL

A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia

This research study is for adults aged 18 to 65 who have just been diagnosed with a type of blood cancer called acute lymphoblastic leukaemia (ALL). It's a large study, happening across multiple countries, investigating new ways to treat ALL. The main goal is to see if adding newer, targeted medications like blinatumomab or isatuximab to standard chemotherapy, or changing how bone marrow transplants are used, can lead to better outcomes for patients. The study is divided into three groups based on the specific type of ALL, and doctors will carefully monitor how safe and effective these new approaches are. The hope is to improve long-term recovery rates and reduce the chances of the cancer coming back.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

1,200

Start

06 May 2025

Estimated completion

15 Mar 2035

Acute Lymphoblastic Leukemia

What is this study about?

Acute lymphoblastic leukaemia (ALL) is a type of cancer that affects the blood and bone marrow. While treatments have improved, especially for younger adults, doctors are always looking for ways to make them even better. This is because although many people respond well to initial treatment, the cancer can sometimes come back, and current survival rates could still be improved.

This study, called GRAALL-2024, is an important step in that direction. It focuses on finding the best first treatments for adults newly diagnosed with ALL. Researchers are particularly interested in combining standard chemotherapy with newer medications that specifically target cancer cells, or using them in clever new ways. These include drugs like blinatumomab and isatuximab, which are designed to help the body's own immune system fight the cancer. The study also aims to figure out exactly which patients would benefit most from a bone marrow transplant, which is a powerful treatment but also has risks.

The study is split into three main groups, depending on the specific type of ALL a person has. By looking at these different groups separately, the researchers hope to tailor treatments more effectively. The ultimate goal is to find new and safer ways to treat ALL from the very beginning, reduce the risk of the cancer returning, and ultimately increase the number of patients who have a full and lasting recovery. This research could change how ALL is treated in the future.

Key takeaways

This study explores new and improved treatments for ALL.
It combines standard and cutting-edge medicines.
Aims to achieve better long-term recovery rates.
Suitable for adults aged 18-65 with new ALL diagnosis.
Patients will be closely monitored throughout.

Who may be eligible?

This study is looking for adults aged between 18 and 65 years old who have recently been diagnosed with acute lymphoblastic leukaemia (ALL). You must not have received any previous treatment for your ALL, apart from some initial steroid or spinal fluid treatments given to control a pre-existing condition. Your doctors will need to do specific tests on your cancer cells to determine if you fit into one of the study's groups.

To be eligible, you also need to be generally well enough to take part in a demanding treatment plan. This means your heart should be healthy, and you shouldn't have any severe ongoing health problems like serious liver disease or certain brain conditions (unless your leukaemia affects the brain and is well-controlled). Your doctors will check these things carefully.

If you are a woman who could become pregnant, or a man whose partner could become pregnant, you would need to agree to use effective contraception during and for a period after the study. You also need to be willing to follow all the study's instructions and attend appointments as required.

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 between 18 and 65 years old?
Have you just been diagnosed with ALL?
Have you only had steroids or spinal fluid treatment so far (if any)?
Is your heart generally healthy?
Are you able to attend appointments regularly?

Answer every question to see your result.

What does participation involve?

If you join this study, it means you will receive your ALL treatment as part of a carefully planned research programme. The specific drugs you receive will depend on the type of ALL you have and will involve a combination of chemotherapy and potentially one of the newer targeted medications like blinatumomab or isatuximab. Some patients might also have a bone marrow transplant, if deemed suitable.

Taking part will involve regular hospital visits for treatments, check-ups, and tests like blood tests and scans, to monitor how you're responding and to check for any side effects. You'll also be asked to report on your symptoms and how you're feeling. The study will involve a treatment phase, followed by a period where your health is regularly monitored. The total duration of your involvement could range from several months to a few years, depending on your treatment plan and follow-up schedule.

Potential risks and benefits

Taking part in this study could offer the potential benefit of receiving some of the newest and most advanced treatments for ALL, which might lead to better response rates and a lower chance of the cancer coming back compared to standard approaches. However, all medical treatments carry potential risks. The experimental treatments might have side effects that are not yet fully known, or could be more severe than standard treatments. You will be closely monitored for any side effects, and your medical team will do their best to manage them. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Hôpital Saint Louis
Verified postcode
Paris, France· Recruiting

Common questions

What is Acute Lymphoblastic Leukaemia (ALL)?

ALL is a fast-growing cancer of the blood and bone marrow, affecting white blood cells called lymphocytes.

What are new immunotherapeutic agents?

These are newer drugs that help your body's immune system recognise and fight cancer cells more effectively.

What is a bone marrow transplant (HSCT)?

It's a procedure where damaged bone marrow is replaced with healthy blood-forming stem cells, sometimes from a donor.

What does 'randomized study' mean?

It means you will be randomly assigned to one of the treatment groups, like flipping a coin, to ensure a fair comparison between treatments.

Will I still receive standard treatment if I join?

Yes, the study combines standard chemotherapy with new drugs, or adjusts the use of standard treatments like bone marrow transplants, aiming to improve outcomes.

How to find out more

Nicolas Boissel, MD PhD

nicolas.boissel@aphp.fr 1 42 49 96 43 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.