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Study on Adding Blinatumomab to Treatment for Adults with Precursor B-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 Precursor B-acute lymphoblastic leukemia (B-ALL) in adults. The study is testing a treatment called Blinatumomab, which is a special type of protein designed to help the body's immune system target and fight cancer cells. Blinatumomab is given to patients as a solution through a vein, a process known as an infusion.

The purpose of the study is to see how well Blinatumomab works when added to the usual treatment plan for B-ALL. This includes using it during the early phase of treatment and again during a phase called consolidation therapy, which helps to strengthen the initial treatment's effects. The study aims to find out how many patients achieve a state where no minimal residual disease (MRD) is detected after the first phase of consolidation therapy. MRD refers to the small number of cancer cells that might remain in the body after treatment, which can be a sign of how well the treatment is working.

Participants in the study will receive Blinatumomab as part of their treatment plan, and some may receive a placebo. The study will monitor various outcomes, such as the level of MRD after different treatment phases, the response of blood cells to the treatment, and the overall survival of patients. The study will also look at the side effects of the treatment and how the immune cells in the body respond to it. The trial is expected to continue until the end of 2025.

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, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of precursor B-acute lymphoblastic leukemia.

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Prephase therapy

    Initial treatment phase designed to prepare the body for the main treatment.

    This phase may involve medications to stabilize the condition before starting the main therapy.

  3. Step 3

    First consolidation phase with blinatumomab

    Blinatumomab, a medication administered through an intravenous infusion, is used during this phase.

    The goal is to achieve a minimal residual disease (MRD) negative response, indicating a reduction in cancer cells to very low levels.

    Monitoring of MRD levels is conducted to assess the effectiveness of the treatment.

  4. Step 4

    Second consolidation phase with blinatumomab

    A second course of blinatumomab is administered to further reduce cancer cells.

    Continued monitoring of MRD levels to evaluate treatment progress.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor health status and detect any potential relapse.

    Assessment of overall survival and event-free survival, which measures the time without cancer progression or recurrence.

Who can join the trial?

6 criteria

  • The patient must have a type of blood cancer called **Precursor B-acute lymphoblastic leukemia**. This includes a specific type called **Philadelphia positive/BCR-ABL positive ALL** and another type called **CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL)**. It does not include mature B-cell ALL or B-lymphoblastic lymphoma.
  • The patient must be between the ages of 18 and 70 years old.
  • The patient must have a **WHO performance status** of 0 to 2. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, while 2 means the person is up and about more than half the day but may not be able to work.
  • If the patient is able to become pregnant, they must have a negative pregnancy test before joining the study.
  • The patient must provide **written informed consent**, which means they agree to participate in the study after being fully informed about it.
  • The patient must be capable of giving informed consent, meaning they understand what the study involves and agree to participate.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer besides Precursor B-acute lymphoblastic leukemia cannot participate. This is a specific type of blood cancer.
  • Patients who have not achieved a MRD negative response after the first consolidation phase cannot participate. MRD stands for Minimal Residual Disease, which means the amount of cancer cells that remain after treatment.
  • Patients outside the age range of 3 to 4 years old cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Both male and female patients are eligible, but those who do not meet other criteria cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups like children or those with certain health conditions.
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Investigated drugs

Blinatumomab is a medication used in this trial to treat adults with precursor B-acute lymphoblastic leukemia. It is added to the prephase and consolidation therapy to help the immune system target and destroy cancer cells. The goal is to achieve a response where minimal residual disease (MRD) is not detectable after the first consolidation phase.

What is already known about the treatment

Blinatumomab – This medication is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating precursor B-acute lymphoblastic leukemia, a type of blood cancer. Blinatumomab works by engaging the body's immune system to target and destroy cancer cells. It belongs to a class of drugs known as bispecific T-cell engagers, which help the immune system recognize and attack cancer cells.

Investigated diseases

Precursor B-acute lymphoblastic leukemia – 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 primarily occurs in children but can also be found in adults. The disease progresses rapidly, leading to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. As the abnormal cells multiply, they crowd out normal cells, impairing the body's ability to fight infections and carry oxygen. The condition requires prompt medical attention to manage the rapid growth of these cancerous cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511050-44-00Protocol codeHOVON 146 ALLEstimated enrolment71 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

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