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Study of blinatumomab plus drug combination in children and adolescents with acute lymphoblastic leukemia

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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 children and adolescents with acute lymphoblastic leukemia. The purpose of the study is to improve the outcome of these patients by testing a new treatment approach that adds a targeted immunotherapy to standard therapy.

Participants receive a combination of chemotherapy drugs that are standard for this disease, given either through a vein or by mouth. The chemotherapy includes methotrexate, cyclophosphamide, mercaptopurine, vinorelbine, pegaspargase, cytarabine, dexamethasone, tioguanine, recombinant l-asparaginase, and doxorubicin. In the experimental part, patients also receive a short course of the targeted immunotherapy drug blinatumomab, which helps the immune system recognize and attack leukemia cells. Treatment is given in several cycles over a few months, followed by regular check‑ups to monitor health, any side effects, and whether the disease returns, while recording disease‑free survival, overall survival, hospital stay length, and quality of life.

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

    Start of treatment

    On the first day after joining the study you will receive a series of intravenous chemotherapy drugs. each drug is given at a dose based on your body surface area (mg/m2). the drugs include:

    methotrexate – 5000 mg/m2 given intravenously,

    cyclophosphamide – 500 mg/m2 given intravenously,

    vincristine (listed as vinorelbine) – 2 mg given intravenously,

    doxorubicin – 30 mg/m2 given intravenously,

    cytarabine – 75 mg/m2 given intravenously,

    dexame thasone – 10 mg/m2 given orally (often taken daily),

    pegaspargase – 3750 IU given intravenously,

    recombinant l‑asparaginase (enrylaze) – 50 mg/m2 given intravenously.

  2. Step 2

    Oral chemotherapy during early phase

    In addition to the intravenous medicines you will take oral tablets each day as prescribed. the oral drugs are:

    mercaptopurine – 100 mg/m2 taken by mouth,

    tioguanine – 60 mg/m2 taken by mouth.

  3. Step 3

    Post‑induction reduced‑intensity therapy with blinatumomab

    After completing the initial chemotherapy you will start a reduced‑intensity post‑induction regimen. this phase includes a continuous intravenous infusion of blinatumomab at a dose of 28 µg per day.

    The blinatumomab infusion is given every day for 28 consecutive days, replacing the standard post‑induction chemotherapy that would otherwise be used.

  4. Step 4

    Maintenance therapy

    Following the 28‑day blinatumomab infusion you will continue with long‑term maintenance treatment. this phase consists of daily oral tablets of mercaptopurine (100 mg/m2) and tioguanine (60 mg/m2), together with scheduled doses of oral dexame thasone (10 mg/m2) as directed by the protocol.

    Maintenance therapy continues for the remainder of the study protocol, which may extend for several months as defined by the trial schedule.

  5. Step 5

    Regular follow‑up assessments

    Throughout the trial you will attend scheduled clinic visits for monitoring. during each visit blood tests and other examinations are performed to check how well the treatment is working and to watch for side effects.

    The timing of these visits follows the trial schedule and may occur weekly during intensive phases and less frequently during maintenance.

Who can join the trial?

12 criteria

  • Be a child or teenager who has just been diagnosed with acute lymphoblastic leukemia (ALL), a type of blood cancer that affects white blood cells.
  • Be newly diagnosed with mixed phenotype acute leukemia (MPAL), which means the cancer shows features of more than one blood‑cell type, and meet one of these conditions:
    • Having two cell types (biphenotypic) but mainly a lymphatic (immune‑system) cell type.
    • Having two cell types (bilineal) with a dominant lymphoblastic (immature lymphocyte) population, or another clear reason to treat with an ALL‑based therapy.
    • Be younger than 18 years old (up to 17 years and 365 days) on the day the disease is diagnosed.
    • Provide written informed consent for the screening part of the study, meaning you agree to the initial checks and understand what will happen.
    • For the B/SR sub‑study, have either:
      • A new diagnosis of ALL that involves B‑cell immune cells, or
      • MPAL that is biphenotypic with a dominant B‑cell lineage.
      • Fit the criteria for the standard‑risk B‑ALL group, which means the disease is considered lower risk based on clinical factors.
      • Have already received the first part of standard‑of‑care (SOC) treatment for low‑risk B‑ALL, which includes:
        • A short course of the steroid prednisone before main therapy (pre‑phase),
        • The initial intensive chemotherapy (induction) called Protocol IA’, and
        • The start of the first consolidation phase (Consolidation A).
        • Give written informed consent to join the trial and allow your data to be transferred and processed. The child’s assent (agreement) must also be obtained when appropriate for their age.

Who cannot join the trial?

17 criteria

  • Having Philadelphia chromosome‑positive (Ph+) acute lymphoblastic leukemia, which means a specific genetic change called BCR::ABL1 or t(9;22) is present.
  • Being younger than 1 year old with a KMT2A‑rearranged B‑ALL, unless a special study exists for those patients.
  • Receiving chemotherapy drugs (cytostatic drugs) before the leukemia was diagnosed, except for a small amount of cytarabine (up to 100 mg per square meter of body surface for no more than 2 days) or a single dose of intrathecal triple therapy (prednisolone, cytarabine, and methotrexate) given into the spinal fluid.
  • Taking glucocorticoid steroids (such as prednisolone) at a dose of 1 mg per kilogram of body weight per day or more for more than two weeks during the month before the leukemia diagnosis.
  • Having another serious health problem that would prevent treatment according to a standard leukemia protocol, such as severe congenital heart disease, Charcot‑Marie‑Tooth syndrome, or ataxia‑telangiectasia.
  • Having any other condition (present at diagnosis) that would significantly conflict with the standard leukemia treatment.
  • Having leukemia that is a second malignancy after previous chemotherapy and/or radiation therapy.
  • Being pregnant or breastfeeding.
  • Having hypersensitivity (allergy) to the active substance blinatumomab or any of its ingredients.
  • Being a sexually active adolescent who does not agree to use a highly effective contraceptive method (with a failure rate less than 1%) for the required time after treatment (6 months for females, 90 days for males).
  • Participating in another clinical trial, unless it is an approved supportive‑care add‑on study.
  • Having mixed‑phenotype acute leukemia (MPAL) that meets criteria for a bilineal acute leukemia with both lymphoid and non‑lymphoid blast groups.
  • Having a clinically important CNS (central nervous system) pathology that needs treatment, such as uncontrolled epilepsy.
  • Having a known infection with human immunodeficiency virus (HIV).
  • Receiving a live vaccine within 2 weeks before starting the study treatment.
  • Having any other significant disorder, condition, or disease that the investigator believes would pose a risk to safety or interfere with the study.
  • Having other ABL‑class gene fusions, unless a specific study exists for those patients or treatment with a tyrosine‑kinase inhibitor is planned.
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Investigated drugs

  • Methotrexate

    is a chemotherapy medicine that blocks the ability of leukemia cells to grow and divide. In this study it is given by IV infusion as part of the intensive treatment schedule to help eliminate cancer cells.

  • Cyclophosphamide

    is a chemotherapy drug that damages the DNA of rapidly growing cells, including leukemia cells. It is administered intravenously in the trial to add extra killing power to the treatment regimen.

  • Mercaptopurine

    is an oral chemotherapy pill that interferes with the production of DNA in leukemia cells, slowing their growth. Patients take it by mouth during the maintenance phase of therapy to keep the disease under control.

  • Vinorelbine

    (listed as VINCRISTINE) is a chemotherapy agent given by IV that stops cancer cells from dividing by disrupting their internal scaffolding. It is used in the trial as part of the combination chemotherapy to increase the overall effectiveness against leukemia.

  • Pegaspargase

    is an enzyme that removes the amino acid asparagine, which many leukemia cells need to survive. Given intravenously, it helps starve the cancer cells and is included in the protocol as a targeted component of the chemotherapy backbone.

  • Blinatumomab

    (marketed as BLINCYTO) is a special immunotherapy that connects a patient’s own immune cells to leukemia cells, directing the immune system to attack the cancer. In the trial it is given as a continuous IV infusion for 28 days, replacing part of the standard post‑induction chemotherapy for certain low‑risk patients.

What is already known about the treatment

  • Methotrexate

    given by intravenous injection, this drug is an approved chemotherapy used worldwide for many cancers including childhood leukemia. It works by blocking an enzyme that helps cells make DNA, which slows the growth of cancer cells. It is classified as an antimetabolite. Its main use in this trial is to treat acute lymphoblastic leukemia.

  • Cyclophosphamide

    administered intravenously, this well‑known drug is an approved alkylating chemotherapy for many solid tumors and blood cancers. It adds a chemical group to DNA, causing the strands to break and the cancer cells to die. It belongs to the alkylating agents class and is used here to fight acute lymphoblastic leukemia.

  • Mercaptopurine

    taken by mouth as tablets, this approved medication is an antimetabolite used for leukemia and other cancers. It mimics a natural building block of DNA and stops cancer cells from copying their genetic material. It is classified as a purine analogue and is included in the protocol to treat acute lymphoblastic leukemia.

  • Vinorelbine

    delivered by intravenous infusion, this drug is an approved chemotherapy belonging to the vinca alkaloid family. It stops cancer cells from forming the fibers needed for cell division, which halts their growth. It is used in the trial as part of the combination therapy for acute lymphoblastic leukemia.

  • Pegaspargase

    given by intravenous injection, this enzyme drug is approved for treating acute lymphoblastic leukemia and is considered an essential component of modern therapy. It breaks down the amino acid asparagine, which leukemia cells need to survive, leading to their death. It is classified as an asparaginase enzyme and is used to improve outcomes in childhood ALL.

  • Blinatumomab

    administered as a continuous intravenous infusion, this drug is an approved, orphan‑designated therapy for acute lymphoblastic leukemia. It links T‑cells to leukemia cells, directing the immune system to kill the cancer cells. It belongs to the class of bispecific T‑cell engager antibodies and replaces part of standard chemotherapy in the trial.

Investigated diseases

Acute lymphoblastic leukemia - A fast‑growing cancer that starts in the bone marrow, where immature lymphoid cells (lymphoblasts) multiply uncontrollably. These abnormal cells enter the bloodstream and can spread to the spleen, liver, and central nervous system. As the number of leukemia cells increases, normal blood formation is reduced, leading to fatigue, easy bruising, and infections. The disease often progresses quickly, with symptoms worsening as more healthy blood cells are displaced. In children and adolescents, the condition typically develops over weeks to months.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-522190-11-01Protocol codeAIEOP-BFM ALL 2025Estimated enrolment3 150 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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