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A study to evaluate the safety and effectiveness of subcutaneous blinatumomab in adults and adolescents with relapsed, refractory, or minimal residual disease positive B-cell precursor acute lymphoblastic leukemia.

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What is this trial about?

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

This study focuses on B cell Precursor Acute Lymphoblastic Leukemia, a type of cancer that affects the blood and bone marrow. The research specifically involves individuals with Relapsed or Refractory B-ALL, which means the cancer has returned after previous treatment or has not responded to existing therapies. It also includes those with Minimal Residual Disease Positive (MRD+) B-ALL, a condition where very small amounts of cancer cells remain in the body even after treatment. The purpose of the study is to evaluate the safety and effectiveness of a new way to give the drug blinatumomab through a subcutaneous injection, which means the medicine is injected just under the skin rather than into a vein.

The study compares two different versions of the medication, referred to as SC1 and SC2. Other medications used as background treatments may include cytarabine, cyclophosphamide, dexamethasone, methotrexate, vincristine sulfate, and levetiracetam. Researchers will monitor how the body processes the medication, a process known as pharmacokinetics, and check for any side effects. The study is conducted in stages, starting with finding the right dose and then observing how well the treatment works in different groups of patients.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Background treatment

    During the study, certain background medications are administered to support your care.

    These include cytarabine, cyclophosphamide, dexamethasone, methotrexate, and vincristine sulfate, which are given as an intravenous injection, meaning they are delivered directly into a vein.

    The medication levetiracetam may also be provided as an oral medicine, which is taken by mouth.

  2. Step 2

    Test medication administration

    The primary focus of the study involves receiving blinatumomab.

    This medicine is given as a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.

    Depending on the specific group assigned, you will receive either the subcutaneous formulation 1 (sc1) or the subcutaneous formulation 2 (sc2).

  3. Step 3

    Monitoring and evaluation

    Throughout the process, safety and effectiveness are monitored.

    This includes checking how the body processes the medicine, known as pharmacokinetics, and observing for any adverse events, which are side effects or unexpected medical occurrences.

    The study also evaluates remission, which is a state where signs of the disease are greatly reduced or undetectable.

Who can join the trial?

14 criteria

  • The patient or their legal representative must provide informed consent, which is a signed document showing they understand and agree to participate in the study.
  • Participants must have a history of B cell precursor acute lymphoblastic leukemia, which is a type of cancer affecting certain white blood cells.
  • For some parts of the study, the patient must have had a relapse (the cancer returned after treatment) or have refractory disease (the cancer did not respond to treatment).
  • For some parts of the study, the patient must have experienced a relapse after receiving an allogeneic hematopoietic stem cell transplant (a procedure where healthy blood-forming cells are taken from a donor and put into the patient).
  • The patient must have at least 5% blasts, which are immature, abnormal cancer cells, in their bone marrow (the soft tissue inside bones where blood cells are made).
  • For the Minimal Residual Disease (MRD) group, the amount of remaining cancer cells in the bone marrow must be between 0.1% and 5%.
  • The patient must have an ECOG Performance Status of 2 or less, which is a scale used by doctors to measure how well a person can perform daily activities and their level of disability.
  • Depending on the specific group, patients must meet certain age requirements: 18 years or older, between 12 and 17 years old, or between 16 and 18 years old.
  • Teenagers may be required to have a Karnofsky Performance Score or a Lansky Performance Score of 50% or higher, which are tools used to measure a patient's ability to function and care for themselves.
  • Patients in the MRD group must have available archival bone marrow specimens, which are stored samples of bone marrow from previous diagnoses.
  • For the MRD group, bone marrow function must meet specific levels for absolute neutrophil count (a measure of certain white blood cells that fight infection), platelet count (cells that help blood clot), and hemoglobin (a protein in red blood cells that carries oxygen).
  • In the Ph-IIRb extended cohort, the patient must weigh less than 45 kg.
  • Patients with extra medullary disease, which means cancer cells found outside of the bone marrow but not in the central nervous system, are eligible if the amount is less than 5%.
  • Participants in the Ph-IIC group must agree to additional pharmacokinetic (PK) sampling, which involves collecting samples to see how the body processes the medicine.

Who cannot join the trial?

19 criteria

  • You cannot participate if you have active leukemia in the Central Nervous System (CNS), which is the part of the body that includes the brain and spinal cord. This includes having too many white blood cells (a type of immune cell) in your cerebrospinal fluid (the clear liquid that surrounds the brain and spine).
  • You cannot join if you have extramedullary (EM) disease, which means the leukemia is growing in parts of the body outside of the bone marrow, or if there are leukemia cells circulating in your blood.
  • You cannot participate if you have testicular leukemia.
  • You cannot join if you have received chemotherapy (medicine used to kill cancer cells) within 2 weeks of starting this study, unless it was a specific low dose or a specific type of treatment for the brain.
  • You cannot participate if you have received immunotherapy (a type of treatment that helps the immune system fight cancer) within 4 weeks of starting this study.
  • You cannot join if you are currently in another medical study testing a new drug or device, or if you finished one less than 30 days ago.
  • You cannot participate if your total bilirubin (a yellowish substance produced by the liver) is too high, which may indicate liver issues, unless you have a specific inherited condition like Gilbert's disease.
  • You cannot join if your creatinine clearance (a measure of how well your kidneys filter waste) is too low, which indicates poor kidney function.
  • Women who are pregnant, breastfeeding, or planning to become pregnant or donate eggs cannot participate.
  • Women of childbearing age who are unwilling to use a highly effective form of contraception (birth control) cannot participate.
  • You cannot join if you are unlikely to be able to finish all the required study visits or follow the study rules.
  • You cannot participate if you have a history of serious brain or nervous system issues, such as epilepsy (seizures), stroke, dementia, or Parkinson's disease.
  • You cannot join if you have an autoimmune disease (a condition where the body's immune system attacks its own healthy cells) that could affect the brain or nervous system.
  • You cannot participate if you have graft versus host disease (a condition where transplanted immune cells attack the recipient's body) that requires strong medicine to suppress the immune system.
  • You cannot join if you have a known hypersensitivity (an allergy) to the study drug or any of its ingredients.
  • You cannot participate if you have an infection with HIV, hepatitis B, or hepatitis C.
  • You cannot join if you have any active or uncontrolled infections or other medical conditions that could be made worse by this treatment.
  • You cannot participate if you have had a different type of cancer within the last 3 years, except for certain skin or early-stage cancers that were fully treated.
  • You cannot join if you have had an allogeneic HSCT (a type of bone marrow or stem cell transplant from a donor) within 12 weeks of starting the study.
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Investigated drugs

  • Blinatumomab

    is the primary medication being tested in this study. It is an immunotherapy treatment given as an injection under the skin to help the body's immune system find and attack certain types of leukemia cells.

  • Cytarabine

    is a chemotherapy medication used as part of the background treatment to help kill cancer cells.

  • Cyclophosphamide

    is a chemotherapy medication used as part of the background treatment to help kill cancer cells.

  • Dexamethasone

    is a steroid medication used as part of the background treatment, which can help reduce inflammation or swelling.

  • Methotrexate

    is a chemotherapy medication used as part of the background treatment to help prevent cancer cells from growing.

  • Vincristine sulfate

    is a chemotherapy medication used as part of the background treatment to help kill cancer cells.

What is already known about the treatment

  • Cytarabine

    This medication is administered through an intravenous injection into a vein and is widely used in medical practice to treat various types of blood cancers. It belongs to a group of drugs called antimetabolites that work by interfering with the production of DNA, which prevents cancer cells from growing and multiplying. This action effectively stops the rapid division of leukemia cells in the body.

  • Cyclophosphamide

    This drug is given through an intravenous injection to treat several types of cancer and certain immune system disorders. It is classified as an alkylating agent, which means it works at a molecular level by attaching to the DNA of cancer cells to damage them and prevent cell reproduction. By breaking the DNA structure, it helps stop the growth of malignant cells.

  • Blinatumomab

    This specialized medication is administered as a subcutaneous injection under the skin and is currently used to treat specific types of B-cell leukemia. It belongs to a class of drugs known as BiTE (Bispecific T-cell Engager) antibodies. It works by acting as a bridge that physically connects the patient's own immune cells to the cancer cells, allowing the immune system to recognize and destroy the leukemia.

  • Dexamethasone

    This is a potent steroid medication administered via intravenous injection to manage inflammation and certain cancers. It belongs to a class of drugs called corticosteroids that work by decreasing the activity of the immune system and reducing swelling in the body. At a molecular level, it regulates genes to limit the production of substances that cause inflammation and immune responses.

  • Methotrexate

    This medication is typically given through an intravenous injection and is commonly used to treat cancer and various inflammatory diseases. It is classified as an antimetabolite that works by blocking a specific enzyme needed for the body to create DNA. By preventing this essential building block from forming, the drug stops cancer cells from dividing and spreading.

  • Vincristine sulfate

    This drug is administered through an intravenous injection and is a well-established treatment for several types of cancer, including leukemia. It belongs to a group of medications called vinca alkaloids that work by interfering with the cell's ability to divide. Specifically, it prevents the formation of the internal structures that pull cells apart during division, thereby stopping cancer cell growth.

Investigated diseases

B cell Precursor Acute Lymphoblastic Leukemia - This is a type of cancer that affects the white blood cells, specifically the precursor cells that eventually become B cells. The disease is characterized by the rapid production of abnormal cells in the bone marrow. These cancerous cells crowd out healthy blood cells, which can lead to various issues with blood function. The condition can progress through different stages, sometimes returning after an initial period of improvement. In some cases, tiny amounts of cancer cells remain in the body even after treatment, a state known as minimal residual disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506136-32-00Protocol code20180257Estimated enrolment202 patientsSponsorAmgen Inc.

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