AvailableEXPANDED_ACCESS

Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease

This is an early access program for a medicine called inolimomab (also known as Leukotac). It's for adults and children over 28 days old who have a serious condition called acute graft-versus-host disease (GvHD). This condition can happen after a stem cell transplant and means the new immune cells attack the patient's body. Often, standard steroid treatments don't work well or patients become dependent on them. This program offers inolimomab to those patients. While inolimomab isn't yet officially approved for sale, past studies have suggested it could help patients live longer when steroids alone haven't been enough to control their GvHD.

At a glance

Status

Available

Sponsor

ElsaLys Biotech

Steroid Resistant Acute Graft Versus Host Disease

What is this study about?

When someone has a stem cell transplant, they receive new immune cells. Sometimes, these new cells mistakenly see the patient's body as 'foreign' and attack it. This reaction is called graft-versus-host disease, or GvHD. If this reaction happens quickly, it's called acute GvHD, and it can be a very serious problem. Doctors often first try to treat acute GvHD with special medications called corticosteroids (steroids).

However, for up to half of all patients, steroids don't fully work or stop working over time. This is known as steroid-resistant GvHD, and it's a very difficult condition to treat, as there aren't many other good options available. This early access program is looking at a new medicine called inolimomab (also known as Leukotac) for these patients.

Inolimomab is a special type of antibody that works by targeting specific immune cells (T-cells) that are involved in GvHD. Studies have shown that inolimomab might help these very sick patients to live longer, especially when compared with other existing treatments. Because it's not yet fully approved for sale, this program allows patients who desperately need it to access it earlier.

Key takeaways

This program offers early access to inolimomab for severe GvHD.
It's for people whose GvHD isn't responding to standard steroid treatment.
Both adults and children over 28 days old can be considered.
Previous studies suggest inolimomab might help people live longer.
Participation will involve regular check-ups and monitoring.
This medicine is not yet formally approved for everyone.

Who may be eligible?

This early access program is for people who have acute graft-versus-host disease (GvHD) that is getting worse or not getting better despite being treated with steroids, or if they need to keep taking steroids to control it. You must be at least 28 days old to be considered.

To be eligible, your acute GvHD needs to be at a certain level of severity, classified as 'Grade II-IV' according to a standard medical guide called the Glucksberg classification. This condition must have developed after you received an allogeneic hematopoietic stem cell transplant, which is a type of bone marrow transplant using donor cells.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, you would not be able to take part in this program.

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 at least 28 days old?
Do you have acute graft-versus-host disease (GvHD)?
Did you have an allogeneic (donor) stem cell transplant?
Is your GvHD not getting better with steroids, or are you dependent on steroids?
Are you currently pregnant or breastfeeding? (If yes, you likely can't join.)

Answer every question to see your result.

What does participation involve?

This program offers treatment with inolimomab. You will receive the medication as directed by your doctors. Your health will be carefully monitored throughout the program. This will likely involve regular hospital visits, blood tests, and check-ups to see how you are responding to the treatment and to keep an eye on your general health. The exact number of visits and tests will depend on your individual situation and your doctor's assessment.

After you stop receiving the main treatment, there will be a longer-term follow-up period. This is important to understand the effects of the treatment over time. The information from all participants helps doctors learn more about the medicine. The total duration of your participation, including follow-up, will be determined by the doctors involved in your care and the program's guidelines.

Potential risks and benefits

The potential benefit of joining this program is gaining access to a medicine that past studies suggest could help improve survival in patients with severe, steroid-resistant GvHD, where other treatments haven't worked. However, no medicine is without potential risks. Inolimomab may have side effects, and your medical team will discuss these with you. It's important to remember that this medicine is not yet fully approved for general sale. Participating in a program like this is completely voluntary, and you have the right to withdraw at any time without explaining your decision or affecting your future medical care.

Locations (1)

ElsaLys Biotech
Verified postcode
Lyon, France· Available

Common questions

What is acute graft-versus-host disease (GvHD)?

It's a serious complication after a stem cell transplant where the donor's immune cells attack the patient's body.

What does 'steroid-resistant' mean?

It means that regular steroid medications are not working well enough to control the GvHD.

Is inolimomab a new medicine?

Yes, it's a newer medicine not yet fully approved for general use, but it's available through this early access program.

Can children join this program?

Yes, children who are at least 28 days old can be considered for this program if they meet the other criteria.

What type of transplant do I need to have had?

You must have had an allogeneic hematopoietic stem cell transplant, which means you received stem cells from a donor.

How to find out more

Raphaele Beaudet

relationshospitalieres_rb@elsalysbiotech.com +33 (0) 6 85 06 46 23 Official trial record

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