AuthorisedTherapeutic confirmatory (Phase III)Interventional

Reduced post-transplant cyclophosphamide dose in patients undergoing haploidentical hematopoietic stem cell transplantation for hematological malignancies: a phase III randomized study (REDUCy)

This research study, called REDUCy, is looking at whether giving a smaller dose of a drug called cyclophosphamide after a stem cell transplant can be better for people with blood cancers. These patients are receiving a specific type of transplant where the stem cells come from a half-matched donor, often a family member. The main goal is to see if patients survive longer without serious side effects from the transplant, the cancer coming back, or problems from the treatment itself. The study also looks at overall survival, quality of life, and how often infections or other issues occur after the transplant. It involves adult patients in France and aims to find a safer and more effective way to help people recover from their cancer treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

180

Start

11 Jul 2025

The study will involve adult women and men from 16 French centers who have hematological malignancies and are candidates for haploidentical HSCT

What is this study about?

This study is exploring a new way to give a treatment called cyclophosphamide, which is often used after a specific type of stem cell transplant. Stem cell transplants are complex procedures used to treat blood cancers. Sometimes, the donor's immune cells can attack the patient's body, which is called graft-versus-host disease (GVHD). Cyclophosphamide helps prevent this serious complication, but it can also have its own side effects.

The specific type of transplant this study focuses on is called a 'haploidentical' transplant. This means the donor is only 'half-matched' to the patient, often a parent, child, or sibling. These transplants are becoming more common, especially when a fully matched donor isn't available. The researchers want to know if giving a reduced dose of cyclophosphamide after this type of transplant can still prevent GVHD effectively, but with fewer side effects from the drug itself. They are hoping to find a 'sweet spot' – enough medication to keep GVHD and the cancer away, but not so much that it causes unnecessary problems.

The main thing the researchers are looking at is how many patients stay healthy and free from major problems like severe GVHD, the cancer coming back, or serious drug side effects, for at least two years after their transplant. They will also be checking on general survival, the patient's quality of life, and how the body recovers after the transplant, including whether infections occur or if organs are affected. The findings from this study could help doctors worldwide improve care for people with blood cancers needing stem cell transplants.

Key takeaways

This study investigates a lower dose of a drug after stem cell transplants.
It aims to reduce side effects while keeping blood cancer away.
The focus is on specific 'half-matched' donor transplants.
You would receive close medical monitoring for two years.
The study assesses survival, quality of life, and complications.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. You also need to have been diagnosed with a blood cancer that requires a type of stem cell transplant where the donor is 'half-matched' to you. This is known as a haploidentical transplant.

Since the study is taking place across 16 different medical centers in France, you would need to be a patient at one of these hospitals. Both men and women are welcome to take part in this research.

There might be other specific health requirements or conditions that your doctor will discuss with you to make sure the study is a safe and suitable option for your unique situation.

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 blood cancer requiring a stem cell transplant?
Are you a candidate for a 'haploidentical' (half-matched) donor transplant?
Are you able to participate at one of the study centers in France?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a stem cell transplant, and then you would be given cyclophosphamide, a medication, either at the standard dose or a reduced dose – this would be decided randomly, like flipping a coin. You wouldn't know which dose you're getting, ensuring the study is fair. Over the next two years, you would have regular hospital visits to monitor your health closely. These visits would involve check-ups, blood tests, and medical assessments.

You would also be asked to fill out two questionnaires at specific times (1, 3, 6, 12, and 24 months after your transplant) to understand your quality of life and how you're feeling. The study will track various aspects of your health, including any infections, how quickly your blood cells recover, and any potential side effects. The total duration of active follow-up for the study's main goals is two years after your transplant.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving very close monitoring of your health during and after your stem cell transplant. It's possible that the reduced dose of cyclophosphamide might lead to fewer side effects while still being effective, potentially improving your recovery and quality of life. However, as with any medical treatment, there are potential risks. The reduced dose might be less effective in preventing GVHD or the return of your cancer, though this is what the study aims to investigate. The standard dose also carries known side effects. Your care team will carefully discuss all known risks associated with the transplant and the medications involved. Remember, you can choose to withdraw from the study at any time without 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 is cyclophosphamide?

Cyclophosphamide is a medicine often used after stem cell transplants to help stop the new immune cells from the donor from attacking your body, a problem called graft-versus-host disease (GVHD).

What is a haploidentical transplant?

This is a type of stem cell transplant where your donor is only a 'half-match' to you, rather than a full match. Often, this is a family member like a parent, child, or sibling.

What does a 'Phase III' study mean?

A Phase III study means the treatment has already been tested in smaller groups, and now researchers are testing it on a larger scale to confirm if it's better or safer than existing treatments.

Will I know if I'm getting the reduced dose or the standard dose?

No, in this type of study, you won't know which dose of cyclophosphamide you receive. This helps to make sure the study results are fair and unbiased.

What is GVHD?

GVHD stands for Graft-versus-Host Disease. It's a serious complication where the donor's immune cells see your body as foreign and start to attack it after a stem cell transplant.