AuthorisedTherapeutic exploratory (Phase II)Interventional

Role of Vitamin D in GVHD prophylaxis in patients undergoing allogeneic transplantation stem cells. Pilot phase II study randomized open monocentric

This study is investigating if giving extra vitamin D (TREDIMIN) can help make a serious condition called Graft-versus-Host Disease (GVHD) less severe after a stem cell transplant. GVHD can happen when the new cells from a donor attack the patient's body. The study is for adults with blood conditions who need a stem cell transplant. It's a phase II study, which means it's an early-stage trial trying to find out if this treatment is effective and safe. They will also look at how vitamin D affects certain cells in the blood and if there are any side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Ospedaliero Universitaria Pisana

Enrolment target

Start

19 Nov 2024

haematologic condition who need staminal cells transplant

What is this study about?

This study is called "Role of Vitamin D in GVHD prophylaxis in patients undergoing allogeneic transplantation stem cells." That's a bit of a mouthful, but in simple terms, it's looking into whether giving vitamin D can help prevent or reduce a problem called Graft-versus-Host Disease (GVHD) in people who are having a stem cell transplant. Stem cell transplants are often used to treat serious blood conditions.

GVHD can be a serious complication after a stem cell transplant. It happens when the new healthy stem cells from a donor (the 'graft') see the patient's body (the 'host') as foreign and start to attack it. This can cause various issues and make recovery harder. Researchers want to see if adding vitamin D to the treatment plan can help make GVHD less severe.

This is a 'Phase II' study, which means it's an early step in testing a new treatment. They are trying to find out if this approach works and if it's safe. They will give some patients a specific type of vitamin D and then check how it affects their GVHD, look at certain cells in their blood, and keep a close eye on any side effects. The goal is to find better ways to help people recover after stem cell transplants.

Key takeaways

This study explores using vitamin D to reduce GVHD after stem cell transplants.
It's for adults (18+) with blood conditions needing a transplant.
The study is in an early stage (Phase II) to check effectiveness and safety.
Participation involves taking vitamin D and regular health checks.
You'll be closely monitored for any side effects.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult patients who need a stem cell transplant because of a blood condition. You must be at least 18 years old to take part, and there's no upper age limit. Both men and women can join the study.

The main thing is that you have a blood condition that requires a stem cell transplant. If you're not sure if your specific condition fits, your doctor will be able to tell you.

There might be other health requirements or reasons why you couldn't join, which your study doctor will explain in full. It's important to discuss your full medical history with them.

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?
Are you scheduled to have a stem cell transplant?
Do you have a blood condition that requires this transplant?
Are you male or female?

Answer every question to see your result.

What does participation involve?

The information provided does not detail the full extent of participation involved. However, it's likely to include regular hospital visits for assessments, blood tests to check your vitamin D levels and other markers, and close monitoring for any side effects. You would be given a specific dose of TREDIMIN, which is an oral vitamin D solution, as part of the study. There would also be follow-up appointments after your transplant to track your health and how well the treatment is working. The total length of your involvement, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as the vitamin D treatment could help reduce the severity of GVHD, which is a complication of stem cell transplants. However, there's no guarantee it will help everyone. There are also potential risks involved, such as side effects from the vitamin D or other treatments, which would be carefully monitored. You would be given detailed information about all possible risks and benefits before deciding to join. Remember, you have the right 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
Italy

Common questions

What is GVHD?

GVHD stands for Graft-versus-Host Disease. It's a complication after a stem cell transplant where the donor's new immune cells attack the patient's body.

What is a stem cell transplant?

A stem cell transplant replaces unhealthy blood-forming cells with healthy ones, often from a donor. It's used for various blood conditions.

What is TREDIMIN?

TREDIMIN is the specific type of vitamin D they are using in this study. It's an oral solution you would take by mouth.

Will I definitely get vitamin D if I join?

Because this study is 'randomized,' you might either receive the vitamin D or standard care, or a placebo, depending on how the study is designed. The study team will explain this fully.

What does a 'Phase II' study mean?

A Phase II study is an early stage of research. It means researchers are testing if a treatment works and is safe in a small group of people, after earlier safety tests.