Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

AAA-IPC 2011-003 - Prospective and multicentre evaluation of 3 different doses of IV busulfan associated with fludarabine and thymoglobuline in the conditioning of allogeneic stem cell transplantation (SCT) from a matched related or unrelated donor in patients with poor prognosis myeloïd malignancies

This study is investigating new ways to treat serious blood cancers that haven't responded well to previous treatments. It focuses on patients receiving a stem cell transplant from a matching donor. Researchers are testing three different doses of a chemotherapy drug called busulfan, along with other anti-cancer medicines (fludarabine and thymoglobuline). The main goal is to find out how long patients live without their cancer getting worse or coming back. They will also look at how effective the treatment is, how new blood cells grow back, and any side effects. This is a Phase II study, meaning it's exploring how well the treatment works and its safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Paoli Calmettes

Enrolment target

177

Start

05 Nov 2024

High-risk myeloïd malignancies

What is this study about?

This research study is about finding better ways to treat certain types of serious blood cancers that have a high risk of coming back or haven't responded well to standard treatments. These specific cancers affect the bone marrow, which is where your blood cells are made.

The study involves patients who are having a stem cell transplant. This is a treatment where healthy blood-forming stem cells from a donor (either a family member or an unrelated donor who is a good match) are given to replace unhealthy ones in the patient's bone marrow. Before the transplant, patients need 'conditioning' treatment, which uses strong medicines to prepare their body for the new stem cells.

In this study, doctors are looking at three different amounts (doses) of a chemotherapy drug called busulfan. This is given alongside two other medicines: fludarabine and thymoglobuline. The main aim is to see how long patients live without their cancer growing or returning. They're also carefully watching for side effects, how well the new stem cells settle in and start making healthy blood, and how the body responds to the treatment overall.

Key takeaways

This study is for serious, high-risk blood cancers.
It tests different doses of chemotherapy before a stem cell transplant.
The main goal is to see how long patients live without their cancer getting worse.
It's a Phase II study, exploring effectiveness and safety.
Participation involves intensive treatment and close monitoring.

Who may be eligible?

To join this study, you would need to be at least 18 years old, and there is no upper age limit. The study is open to both men and women.

Critically, you must have a specific type of serious blood cancer that doctors consider to be high-risk. This means your cancer might be more difficult to treat or has a higher chance of coming back.

Your doctors would check other detailed medical information to make sure this study is the right fit for your health and cancer type. They would explain all the criteria carefully.

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 a type of serious blood cancer that is considered high-risk?
Are you able to have a stem cell transplant from a matched donor?
Are you generally well enough for intensive treatment?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a stem cell transplant, which is a major medical procedure. You would receive the study medications (busulfan, fludarabine, and thymoglobuline) before your transplant. After the transplant, your doctors and nurses would closely monitor your health.

This monitoring would include regular check-ups, blood tests to see how your new blood cells are growing and if the donor cells are working well, and scans to check your cancer. They would also watch for any side effects from the treatment, such as a condition called GvHD (graft-versus-host disease), where the new donor cells react against your body. The follow-up for this study would continue for several months after your conditioning treatment to track your progress and any long-term effects.

Potential risks and benefits

Participating in a study like this might offer the chance to receive a new treatment approach for your high-risk blood cancer that could be more effective. However, there are also potential risks. Chemotherapy and stem cell transplants are intensive treatments with known side effects, which could be serious. The doctors will carefully watch for these effects and manage them as best they can. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your 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 kind of cancer is this study for?

This study is for people with serious types of blood cancers that affect the bone marrow and are considered high-risk.

What is a 'stem cell transplant'?

It's a treatment where healthy blood-forming cells from a matched donor replace unhealthy ones in your body, usually after strong chemotherapy.

What are 'conditioning' treatments?

These are strong medicines, like chemotherapy, given before a stem cell transplant to prepare your body for the new cells.

What is 'Phase II' mean in a study?

Phase II means researchers are exploring how well a new treatment works and if it's safe for people, after it's been shown to be safe in a smaller group.

Will I get different medicines if I join this study?

You will receive a standard chemotherapy drug called fludarabine, another medicine called thymoglobuline, and one of three different doses of busulfan.