AuthorisedTherapeutic exploratory (Phase II)Interventional

Multicenter, open label, phase II clinical trial of inotuzumab ozogamicin as prophylaxis for relapse in patients with high-risk acute B-cell precursor acute lymphoblastic leukaemia after allogeneic stem cell haemotopoietic transplantation

This phase II clinical trial is testing a targeted medicine called inotuzumab ozogamicin (brand name Besponsa). It is for adults with high-risk B-cell acute lymphoblastic leukaemia (ALL) who have recently received a stem cell transplant from a donor. After a stem cell transplant, there is still a chance the leukaemia could return. Doctors call this a relapse. In this trial, participants receive Besponsa as a preventive treatment. The main aim is to find out if the drug can lower the chance of the cancer coming back and help people live longer, healthier lives. Researchers will also carefully monitor safety, tracking side effects and checking how well the new donor immune system settles in. Taking part involves having regular blood tests, bone marrow checks, and hospital visits over roughly two years to keep a close eye on your recovery.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion PETHEMA

Enrolment target

Start

15 Sep 2026

Acute lymphoblastic leukaemia

What is this study about?

Acute lymphoblastic leukaemia (ALL) is a fast-growing cancer of the white blood cells. A common and effective treatment for high-risk ALL is an allogeneic stem cell transplant. This involves replacing a patient's unhealthy bone marrow with healthy stem cells from a donor. While this can cure the disease, there is still a risk that small amounts of leukaemia cells remain hidden, which could cause the cancer to return later on.

This trial is studying a targeted drug called inotuzumab ozogamicin, also known as Besponsa. It works like a guided missile: it attaches to a specific marker found on B-cell leukaemia cells and delivers a powerful medicine directly into them. Doctors want to see if giving this treatment after a transplant can clear away any remaining leukaemia cells before they cause harm.

The main goal of the study is to see how well Besponsa prevents the leukaemia from returning and whether it helps people stay in remission for longer. Doctors will compare the results of people on this trial with similar patients who had standard care without the drug, to see if it provides an extra layer of protection.

Researchers will also monitor the safety of the treatment very closely. They need to ensure that Besponsa does not interfere with how well the donor stem cells grow, or trigger unwanted immune reactions like graft-versus-host disease, where donor cells attack the patient's body.

Key takeaways

This study tests Besponsa to see if it prevents leukaemia returning after a stem cell transplant.
It is designed for adults aged 18 and over with B-cell precursor acute lymphoblastic leukaemia.
The medicine is given as a hospital drip into a vein.
Participants are monitored closely with blood and bone marrow tests for about two years.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

You may be able to join this study if you are 18 or older and have a specific type of blood cancer called B-cell precursor acute lymphoblastic leukaemia. You must have already had an allogeneic stem cell transplant (using cells from a donor) and be considered at higher risk of your cancer returning.

To take part, your cancer must currently be in remission following your transplant. Your new donor stem cells also need to be working properly, and your vital organs—such as your liver and kidneys—must be functioning well enough to safely handle the trial medicine.

You will not be able to take part if you have active, severe graft-versus-host disease, an uncontrolled infection, or significant liver problems. Your hospital haematology team will carry out detailed health checks to make sure the trial is safe and suitable for you.

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.

I am aged 18 or older.
I have been diagnosed with B-cell precursor acute lymphoblastic leukaemia (ALL).
I have had a stem cell transplant using donor cells (allogeneic transplant).
My leukaemia is currently in remission.
I am considered at higher risk of the leukaemia returning.
My liver, kidneys, and overall health are stable enough for treatment.

Answer every question to see your result.

What does participation involve?

If you decide to join this trial, you will receive inotuzumab ozogamicin (Besponsa) as an intravenous infusion (a slow drip into a vein). Treatment is given in hospital under the care of your haematology team. The trial team will closely monitor your dose and adjust it if you experience any troublesome side effects.

You will need to attend regular hospital appointments for check-ups. During these visits, doctors will perform physical examinations, take blood samples, and carry out bone marrow tests at set times (such as at 3, 6, 9, 12, 18, and 22 months post-transplant). These tests check for tiny traces of leukaemia and see how well your immune system is rebuilding.

Your overall participation and follow-up will last for around two years after your stem cell transplant. The team will stay in touch to check on your health and wellbeing throughout this period.

Potential risks and benefits

The main hope of taking part is that the treatment may lower the chance of your leukaemia coming back, helping you stay in remission for longer. However, there is no guarantee of direct benefit. Like all cancer treatments, Besponsa can cause side effects. These may include low blood counts, increased risk of infections, tiredness, nausea, and changes in liver function. In some cases, it can cause a specific liver complication called VOD (veno-occlusive disease). Taking part is entirely voluntary. You can choose to leave the study at any point, and your normal NHS care and relationship with your medical team will not be affected in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is the purpose of this clinical trial?

The trial is testing whether giving the drug Besponsa after a stem cell transplant helps prevent leukaemia from returning in adults with high-risk B-cell ALL.

How is the study medicine given?

Besponsa is given as an infusion (a liquid drip) into a vein, carried out at the hospital by specialist nurses.

Will I have to pay for the trial treatment?

No. In the UK, clinical trial medications and trial-related tests are provided free of charge through the hospital and study sponsor.

What extra tests will I need?

You will need routine blood tests and bone marrow checks at scheduled times over about two years to monitor your leukaemia and immune system.

Can I stop taking part if I change my mind?

Yes. You have the right to withdraw from the trial at any time without giving a reason, and it will not affect your standard medical care.