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Study of Inotuzumab Ozogamicin Alone and with Drug Combination for Children with Relapsed or Refractory 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 treatment for children with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL). The study is specifically for cases where the disease has returned or has not responded to previous treatments. The treatment being tested is called Inotuzumab Ozogamicin, which is used alone or in combination with chemotherapy. The goal of the study is to find the best dose of Inotuzumab Ozogamicin for children and to see how effective it is in treating this type of leukemia.

Inotuzumab Ozogamicin is a medication that targets a specific protein found on the surface of cancer cells, known as CD22. By targeting this protein, the drug aims to destroy the cancer cells while sparing healthy cells. The study will also explore the safety and side effects of the treatment, as well as how well it works in combination with other chemotherapy drugs. The trial is divided into different parts, each focusing on different aspects of the treatment, such as its effectiveness and safety.

Participants in the study will receive the treatment over several cycles, and their response to the treatment will be closely monitored. The study aims to provide valuable information on how Inotuzumab Ozogamicin can be used to treat children with relapsed or refractory ALL, potentially leading to better treatment options in the future. The study is expected to continue until 2027, allowing researchers to gather comprehensive data on the treatment's effectiveness and safety.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Blood tests and imaging may be performed to evaluate the presence of CD22-positive cells.

  2. Step 2

    Treatment initiation

    The treatment begins with the administration of inotuzumab ozogamicin as a single agent or in combination with chemotherapy.

    The medication is given through an intravenous infusion.

  3. Step 3

    Dose determination

    The appropriate dose of inotuzumab ozogamicin is determined based on the patient's response and tolerance.

    This phase aims to establish the maximum tolerated dose or recommended phase 2 dose.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects.

    Blood tests and imaging are repeated to track changes in the disease.

  5. Step 5

    Combination therapy

    For some patients, inotuzumab ozogamicin is combined with a modified chemotherapy regimen.

    This combination aims to enhance the treatment's effectiveness.

  6. Step 6

    Follow-up

    After completing the treatment cycles, follow-up visits are scheduled to monitor long-term outcomes.

    These visits include assessments of overall health and any late effects of the treatment.

Who can join the trial?

10 criteria

  • Patients must be between 1 and 18 years old at the time of joining the study.
  • For certain parts of the study, patients must have a specific type of leukemia called BCP-ALL that has either come back after treatment or not responded to treatment.
  • Patients must have a certain amount of cancer cells in their bone marrow, which is checked by looking at the cells under a microscope.
  • The cancer cells must have a specific marker called **CD22** on their surface, which is checked by a lab test.
  • Patients must have a certain level of physical activity and be expected to live for at least 6 more weeks.
  • Patients must have recovered from any side effects of previous treatments like chemotherapy or radiation before joining the study.
  • Patients must have normal kidney and liver function, which is checked by blood tests.
  • Patients must have normal heart function, which is checked by a heart test.
  • Female patients who can have children must have a negative pregnancy test before joining the study and must not breastfeed during the study.
  • All patients who can have children must agree to use effective birth control during the study and for a period after the study ends.

Who cannot join the trial?

6 criteria

  • Patients who do not have **CD22-positive** relapsed or refractory **Acute Lymphoblastic Leukemia**. This means the leukemia cells must have a specific marker called CD22.
  • Patients who have not experienced a relapse or whose leukemia is not resistant to treatment. **Relapsed** means the cancer has returned after treatment, and **refractory** means it does not respond to treatment.
  • Patients who are not within the specified age range for the study. The study is for children, so adults cannot participate.
  • Patients who have already received a bone marrow transplant during their first complete remission. **Complete remission** means there are no signs of cancer after treatment.
  • Patients with other types of cancer that are not CD22-positive B-cell malignancies. **B-cell malignancies** are cancers that affect a type of white blood cell called B-cells.
  • Patients who are not able to safely tolerate the study medication or procedures. **Tolerate** means being able to handle the side effects or risks of the treatment.
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Investigated drugs

Inotuzumab Ozogamicin is a medication used in this clinical trial to treat children with a specific type of leukemia called CD22-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL). It is being tested both as a single agent and in combination with chemotherapy. The goal is to determine the most effective dose and to evaluate its safety and effectiveness in treating this type of cancer.

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 pediatric patients with CD22-positive relapsed or refractory Acute Lymphoblastic Leukemia (ALL). It is primarily indicated for use in children who have not responded to other treatments. Inotuzumab Ozogamicin works by targeting the CD22 protein on the surface of cancer cells, delivering a toxic agent directly to these cells, which helps to destroy them. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a cytotoxic agent to specifically target and kill cancer cells.

Investigated diseases

Acute Lymphoblastic Leukemia – Acute Lymphoblastic Leukemia (ALL) 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 primarily affects children but can also occur in adults. The disease progresses rapidly, leading to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the abnormal cells accumulate, they can crowd out normal blood cells, causing anemia and increasing the risk of infections. The disease is classified based on the type of lymphocytes affected, either B-cells or T-cells, with B-cell ALL being more common. Treatment typically involves multiple phases, including induction, consolidation, and maintenance therapy, to eliminate cancer cells and prevent relapse.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2023-504694-20-00Estimated enrolment158 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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