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Phase II study of inotuzumab ozogamicin to prevent relapse in adult high‑risk acute lymphoblastic leukaemia patients after allogeneic stem cell transplant

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Acute lymphoblastic leukaemia, a rapidly spreading cancer of the blood‑forming tissue, specifically the high‑risk B‑cell precursor form. After a patient receives an allogeneic stem cell transplantation, a laboratory‑made medicine called inotuzumab ozogamicin is given through an IV to try to keep the disease from coming back.

Participants will first undergo the transplant, then, once they have recovered enough, they will receive a series of infusions of the study drug over several months. Throughout the trial they will have regular doctor visits, blood work, and occasional bone‑marrow checks to see how they are doing and to watch for any side effects.

The main goal of the research is to find out whether this approach can lower the chance of the leukaemia returning after transplant. Safety is also closely watched, with doctors recording any adverse events, changes in laboratory results, and overall health status during the follow‑up period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial enrollment
After signing the consent form, you become a participant in the study.
The study team records your personal information, medical history, and details about your recent stem cell transplant.
Step 2
Baseline assessments
Blood samples are taken to check routine laboratory values.
A bone marrow sample is examined to determine mrD negativity, which means no measurable disease is found.
Additional blood tests evaluate your immune system status before any study medication is given.
Step 3
First infusion of <b>inotuzumab ozogamicin</b>
You receive an intravenous infusion of inotuzumab ozogamicin at a dose of 0.5 mg per square meter of body surface area.
The medication is supplied as a powder that is mixed to create a solution for infusion and is administered through a vein in a clinical setting.
Step 4
Scheduled follow‑up visits
You return for follow‑up appointments at 3, 6, 9, 12, 18, and 22 months after the transplant.
At each visit, blood and bone marrow samples are taken to repeat mrD testing and to assess immune reconstitution.
Routine laboratory tests are performed to monitor organ function and blood counts.
The study team checks for any adverse events (side effects) and records them.
Step 5
Ongoing safety monitoring
Throughout the study period, any side effects you experience are reported to the investigators.
If a side effect is serious, the dose of inotuzumab ozogamicin may be reduced or the treatment may be stopped, according to the study protocol.
Step 6
Final evaluation
At the end of the 22‑month follow‑up, a comprehensive assessment is performed.
The evaluation includes checking for disease relapse, overall survival, and any long‑term side effects.
The results are compared with historical data from patients who did not receive the study medication.

Who can join the trial?

10 criteria

You must be willing and able to keep all scheduled study visits and follow the study rules.
You need to be able to understand what will be done in the study.
You must be at least 18 years old when you sign the consent form.
Your overall health score, called the ECOG performance status, must be 2 or lower. This means you can take care of yourself and are not confined to a bed or chair.
You must have CD22‑positive high‑risk acute lymphoblastic leukemia (ALL). This is true if any of the following applies:
- The disease is classified as high risk by the PETHEMA LAL 2019 guidelines, which look at the amount of remaining cancer after initial treatment (called minimal residual disease) and any chromosome changes (called cytogenetic abnormalities) such as a hypodiploid karyotype, KMT2A/MLL alterations, TP53 deletions or mutations, and IKZF1 or CDKN2A/B deletions.
- You are in your first complete remission (no signs of disease) at the time of the transplant, no matter what the MRD test shows.
- You will receive a stem‑cell transplant from a donor who is either a perfect match (HLA‑identical), a partial match (mismatched or haploidentical) sibling, or an unrelated donor, using any type of conditioning regimen (myeloablative, reduced‑toxicity, or non‑myeloablative).
- Your new blood‑forming system (called hematopoietic engraftment) must be stable, which means:
  - Your white‑blood‑cell count called neutrophils is above 1,000 per microliter for at least three consecutive days.
  - Your platelet count is above 50,000 per microliter for at least seven days without needing transfusions.
  - More than 90% of your blood cells come from the donor, a measure known as donor chimerism, as checked in a blood test.

Who cannot join the trial?

16 criteria

You have already received inotuzumab ozogamicin, the study drug, before joining the trial.
Your liver blood test results (such as bilirubin, GOT, and GPT) are more than twice the normal range.
You have a history of liver disease or a condition called hepatic veno‑occlusive disease/sinusoid obstruction syndrome, which damages small blood vessels in the liver.
You have an active infection with hepatitis B or hepatitis C, which are viral infections of the liver.
You have a fungal infection or another serious infection that is not under control.
You have severe graft‑versus‑host disease (a reaction where transplanted cells attack your body) that is grade 3‑4 acute or grade > 2 chronic affecting the liver.
You are taking sirolimus to prevent graft‑versus‑host disease and cannot stop it before the trial starts.
You have Ph‑positive lymphoblastic leukemia, a type of leukemia with a specific genetic change.
You have not yet recovered normal blood counts after transplant (no haematological recovery).
You have an uncontrolled disease of the heart, kidneys, lungs, or a serious psychiatric (mental health) condition.
You have an active non‑blood‑cancer tumor that is not under control.
You have any serious medical or psychiatric condition that would make it difficult to understand the consent form.
You have any serious medical condition that would place you at an unacceptable risk if you participated in the study.
You are pregnant, breastfeeding, plan to become pregnant during the study, or are not using effective birth‑control methods (such as double barrier, intrauterine device, or oral contraception) if you could become pregnant.
You are receiving a cord blood stem‑cell transplant (cord blood HSCT).
Your kidney function measured by creatinine clearance is less than 30 ml per minute.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital De La Santa Creu I Sant Pau
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Barcelona, Spain
Hospital General Universitario Gregorio Maranon
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Madrid, Spain
Hospital Universitario 12 De Octubre
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Madrid, Spain

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Investigated drugs

Inotuzumab ozogamicin is a medicine that combines a special antibody with a chemotherapy drug. The antibody part seeks out a protein called CD22 that is found on the surface of certain leukemia cells. When it attaches to these cells, the chemotherapy part is delivered directly inside them, helping to kill the cancer cells while sparing many normal cells. In this trial, the medication is given through an IV infusion after the patient has received an allogeneic stem cell transplant. The goal is to use it as a preventive treatment to lower the chance that the leukemia will come back in adults who have high‑risk B‑cell precursor acute lymphoblastic leukemia.

Inotuzumab Ozogamicin

What is already known about the treatment

Inotuzumab ozogamicin - It is given by IV infusion using a powder that is mixed into a solution for administration. The drug is already approved for treating relapsed or refractory B‑cell acute lymphoblastic leukemia and is being studied to prevent relapse after stem‑cell transplantation. It works by a two‑part system: an antibody finds the CD22 protein on leukemia cells and carries a strong toxin that breaks the cell’s DNA, leading to cell death. This medication belongs to the class of antibody‑drug conjugates and is used as an anti‑cancer (antineoplastic) therapy.

Investigated diseases

B‑cell precursor acute lymphoblastic leukemia - A fast‑growing cancer of immature B‑cell precursors that builds up in the bone marrow and spills into the blood. The disease causes a rapid rise in abnormal white‑cell blasts, which can crowd out normal blood cells and lead to fatigue, infections, and easy bruising. As the blast count increases, the marrow becomes less able to produce healthy red cells, white cells, and platelets. The abnormal cells may also travel to the spleen, liver, and central nervous system, expanding the disease beyond the marrow. Without effective control, the number of blasts continues to climb, leading to a relapse after an initial period of remission.