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Study Comparing Inotuzumab Ozogamicin to Drug Combination for Children with High-Risk Relapsed B-cell Acute Lymphoblastic Leukemia

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

This clinical trial is focused on studying a type of blood cancer called Acute Lymphoblastic Leukemia (ALL), specifically in children who have experienced a high-risk first relapse. The study is comparing a new treatment using a medication called Inotuzumab Ozogamicin with a standard treatment known as ALLR3. The purpose of the study is to determine if Inotuzumab Ozogamicin is more effective than the standard treatment in helping children with this type of leukemia.

Participants in the study will receive either Inotuzumab Ozogamicin or the standard treatment. Inotuzumab Ozogamicin is given as an infusion, which means it is administered directly into the bloodstream through a vein. The study will last for a period of up to 28 days, during which the effects of the treatment will be closely monitored. Other medications that may be used in the study include Dexamethasone, Pegaspargase, Vincristine Sulfate, and Mitoxantrone Hydrochloride, which are commonly used in treating leukemia.

The study aims to see if the new treatment can help achieve a state where no cancer cells are detectable in the blood, known as minimal residual disease-negative status. This is an important goal in treating leukemia, as it indicates a better response to treatment. The study will also look at other outcomes, such as the time it takes for the disease to progress, the duration of response to treatment, and overall survival rates. Participants will be monitored for any side effects or adverse events during the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to have a diagnosis of first relapse high-risk B-cell precursor acute lymphoblastic leukemia (ALL).

    The participant is between 1 and less than 18 years old and meets specific health criteria, including adequate kidney and liver function.

  2. Step 2

    Induction treatment

    The participant receives Inotuzumab Ozogamicin as a monotherapy. This medication is administered through an intravenous infusion.

    The goal of this phase is to achieve minimal residual disease (MRD)-negative status, which means reducing the number of leukemia cells to a very low level.

  3. Step 3

    Monitoring and assessment

    Throughout the treatment, the participant's response is closely monitored. This includes regular assessments to check for MRD negativity and overall health status.

    The participant's progress is evaluated to determine if the treatment is effective in achieving complete remission or partial remission.

  4. Step 4

    Secondary outcomes

    Secondary outcomes include measuring event-free survival (EFS), which tracks the time until disease progression, relapse, or other significant events.

    Other outcomes include duration of response (DOR), overall survival (OS), and the incidence and severity of any side effects experienced during the trial.

  5. Step 5

    Completion of trial

    The trial is expected to continue until July 2031, with ongoing assessments and data collection to evaluate the long-term effectiveness and safety of the treatment.

    Participants may continue to receive follow-up care and monitoring as part of the study protocol.

Who can join the trial?

9 criteria

  • Participants must be boys or girls between 1 and less than 18 years old.
  • Participants must have a confirmed diagnosis of first relapse of **high-risk** B-cell precursor acute lymphoblastic leukemia (**BCP ALL**). This means the leukemia has returned within 18 to 30 months after the first diagnosis or within 6 months after finishing the initial treatment, and does not have certain very high-risk genetic changes.
  • The leukemia must be **CD22-positive**, which is a specific marker found on the cancer cells.
  • There must be at least 5% cancer cells in the bone marrow.
  • Participants must have acceptable blood test results, including:
    • Adequate kidney function, measured by a test called **glomerular filtration rate (eGFR)** or **creatinine clearance (eCrCl)**, which should be at least 30 mL/min.
    • Liver enzymes, **aspartate aminotransferase (AST)** and **alanine aminotransferase (ALT)**, should be no more than 5 times the normal limit.
    • Total **bilirubin** should be no more than 1.5 times the normal limit, unless the participant has a condition called **Gilbert's syndrome**.
    • Participants who have had blood clots while using certain medications in the past can join if they receive preventive treatment for blood clots according to guidelines.
    • The heart's ability to pump blood, measured by a test called **echocardiogram** or **MUGA**, should be at least 30% or more than 50%, respectively.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of leukemia other than Acute Lymphoblastic Leukemia (ALL) cannot participate. Leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who are not between the ages of 1 and less than 18 years old are excluded. This means the study is only for children and teenagers.
  • Patients who do not have a specific type of leukemia called CD22-positive B-cell precursor acute lymphoblastic leukemia (BCP ALL) cannot join. This is a specific kind of leukemia that affects certain cells in the blood.
  • Patients who have not experienced a first bone marrow relapse are not eligible. A relapse means the leukemia has returned after treatment.
  • Patients who are not considered high risk (HR) for a first bone marrow relapse are excluded. High risk means there is a greater chance of the leukemia coming back.
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Investigated drugs

Inotuzumab Ozogamicin is a medication used in this clinical trial as a monotherapy. It is being tested to see if it is more effective than the current standard treatment for children who have a high-risk first relapse of a type of blood cancer called B-cell precursor acute lymphoblastic leukemia. This medication works by targeting specific cancer cells and delivering a substance that can help kill these cells.

What is already known about the treatment

Inotuzumab Ozogamicin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Acute Lymphoblastic Leukemia (ALL), particularly in children experiencing a high-risk first relapse. It is a targeted therapy that works by binding to the CD22 protein on the surface of cancer cells, delivering a toxic agent directly to these cells to kill them. Inotuzumab Ozogamicin is classified as an antibody-drug conjugate, combining a monoclonal antibody with a chemotherapy drug to enhance its cancer-fighting capabilities.

Investigated diseases

Acute Lymphoblastic Leukemia (ALL) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells, known as lymphoblasts. It progresses rapidly, leading to an accumulation of these cells in the bone marrow, which interferes with the production of normal blood cells. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. Symptoms may include fatigue, fever, frequent infections, and easy bruising or bleeding. The disease is most common in children, but it can also occur in adults. Early detection and intervention are crucial for managing the progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2023-509810-13-00Protocol codeB1931036Estimated enrolment100 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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