Active not recruitingPHASE2INTERVENTIONAL

UM171 Expanded Cord Blood In Patients With High-Risk Acute Leukemia/Myelodysplasia

This study is investigating a new type of stem cell transplant using 'expanded' cord blood for people with high-risk acute leukaemia or myelodysplasia. Normally, cord blood has too few stem cells, making recovery slow. This new method, called UM171 expanded cord blood, increases the number of these important cells before transplant. Previous research showed this method was safe and led to quicker recovery, with lower risks of serious side effects like transplant-related problems or graft-versus-host disease. This new study hopes to confirm these benefits and see how well this expanded cord blood fights cancer in patients who need powerful new treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrolment target

Start

01 Apr 2019

Estimated completion

01 Jun 2027

High Risk Hematologic Malignancy Cord Blood Transplant

What is this study about?

This study is about a new way to carry out a type of treatment called a stem cell transplant. Stem cell transplants are life-saving procedures for people with certain blood cancers. They involve replacing unhealthy blood cells with healthy ones. One source of these healthy cells is umbilical cord blood, which is collected from a baby's umbilical cord and placenta after they are born. Cord blood has some advantages, such as a lower chance of the cancer coming back and fewer long-term side effects like chronic graft-versus-host disease (where the new immune cells attack the patient's body).

However, cord blood normally has a limited number of stem cells, which can mean a slower recovery and a higher risk of complications after the transplant. This new study uses a special method called 'UM171 expanded cord blood' to increase the number of these vital stem cells before they are transplanted. This expansion process happened in an earlier study and was found to be safe and effective, leading to faster recovery times and a lower chance of serious side effects. Most patients in the earlier study had impressive survival rates.

Now, this new study wants to confirm these promising results in people with very high-risk acute leukaemia or myelodysplasia. These are serious blood cancers that can be difficult to treat with standard methods. The researchers want to see if this 'expanded' cord blood can be even more effective against these aggressive cancers, while still keeping the risks low. They will be looking closely at how well patients recover, if the cancer stays away, and how often side effects occur.

Key takeaways

This study uses a new form of cord blood transplant for high-risk blood cancers.
The cord blood is 'expanded' to increase the number of healthy cells for a faster recovery.
Previous limited tests showed this method was safe with good patient outcomes.
The study aims to confirm if this expanded cord blood effectively fights aggressive cancers.
It targets patients with high-risk acute leukaemia or myelodysplasia.
Participants will receive the transplant after preparation and then have long-term monitoring.

Who may be eligible?

This study is looking for adults aged 18 to 70 who have specific types of high-risk acute leukaemia or myelodysplasia. This means your cancer has either been very difficult to treat, has come back after previous treatments, or has certain genetic features that make it high-risk.

For acute myeloid leukaemia (AML), you might be considered if initial treatments didn't work, if the cancer came back, or if you have specific high-risk features even if it's your first time in remission. Similar criteria apply for acute lymphoid leukaemia (ALL), including cases where previous intensive treatments weren't successful, or if your cancer has certain high-risk genetic characteristics.

If you have myelodysplastic syndrome (MDS), you might be eligible if your cancer has returned after a transplant, if you have a certain percentage of unhealthy cells, difficult genetic changes, or if previous treatments for MDS weren't effective. The study team will look at your specific medical history and test results to see if you meet the detailed requirements.

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 70 years old?
Do you have a diagnosis of high-risk acute leukaemia or myelodysplasia?
Has your cancer been difficult to treat or come back after previous treatments?
Does your leukaemia or myelodysplasia have specific high-risk genetic features?
Are you able to follow a regular schedule of hospital visits and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first receive a special treatment called 'conditioning' to prepare your body for the transplant. This typically involves strong medications to get rid of unhealthy cells. After this, you will receive the UM171 expanded cord blood transplant. This is a one-time procedure, similar to a blood transfusion.

After the transplant, you will have regular medical appointments and tests to monitor your recovery. This includes checking your blood cell counts, looking for any signs of infection, and monitoring for side effects like graft-versus-host disease. The study team will also track how well the new stem cells are working and if the cancer remains in remission. The exact number of visits and tests will vary, especially in the initial period after transplant, and will gradually reduce over time. The total duration of your participation in the study will involve long-term follow-up to assess the lasting effects of the transplant.

Potential risks and benefits

Participating in this study offers the potential benefit of a new and possibly more effective treatment for your high-risk blood cancer, especially if standard treatments haven't worked well. Previous research with this expanded cord blood showed promising survival rates and lower serious side effects compared to traditional cord blood transplants. However, as with any medical procedure, there are potential risks, including side effects from the conditioning treatment, infections, and graft-versus-host disease, although efforts are made to minimise these. Your doctor will discuss all potential side effects with you in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

CIUSSS de l'Est-de-l'île-de Montreal, Hôpital Maisonneuve-Rosemont
Verified postcode
Montreal, Canada

Common questions

What is 'expanded' cord blood?

It's umbilical cord blood that has been treated in a special way to increase the number of healthy blood-forming cells before it's given to you.

What is a 'high-risk' blood cancer?

It means your specific type of leukaemia or myelodysplasia is considered more difficult to treat or has a higher chance of coming back after standard treatments.

Will I still get regular cancer treatment if I join this study?

Yes, the UM171 expanded cord blood transplant is the main treatment being studied, preceded by a preparation treatment. All your care will be closely managed by the study team.

What is graft-versus-host disease (GVHD)?

It's a possible side effect of a stem cell transplant where the new immune cells from the donor see your body as foreign and attack it. This study aims to reduce this risk.

How long will I be followed up if I join the study?

You will be followed up long-term to see how you are doing and to check the lasting effects of the transplant. Your doctor can give you more specific details.