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Study of Blinatumomab and a drug combination for older adults with newly diagnosed Philadelphia-negative B-cell precursor 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 study focuses on older adults with a newly diagnosed type of cancer called B-cell precursor Acute Lymphoblastic Leukemia. Specifically, the study looks at patients who are Philadelphia-negative, which means their cancer cells do not have a specific genetic marker. The purpose of the study is to compare a new treatment approach to the current standard of care to see how well it works and how safe it is.

Participants may receive different combinations of medications. One group will receive blinatumomab alternating with low-intensity chemotherapy, which is a type of treatment that uses drugs to kill cancer cells. The other group will receive the standard of care, which includes medications such as rituximab, cytarabine, dexamethasone, vincristine sulfate, cyclophosphamide, methotrexate sodium, mercaptopurine, prednisone, idarubicin, asparaginase, and doxorubicin. Other substances mentioned in the study include pegaspargase, crisantaspase, and prednisolone.

The study will monitor how long patients live and how long they stay without the cancer returning. Researchers will also look at the minimal residual disease, which refers to the small number of cancer cells that remain in the body after treatment. Additionally, the study will track how the treatments affect the patients' quality of life, including levels of pain, tiredness, and physical function.

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

    <b>study assignment</b>

    After joining the study, one of two treatment paths is assigned.

  2. Step 2

    <b>treatment path 1: blinatumomab and chemotherapy</b>

    This path involves alternating blinatumomab, which is an intravenous (delivered through a vein) medication at a dose of 28 µg, with low-intensity chemotherapy.

    The chemotherapy part of this path includes rituximab administered intravenously at 375 mg/m2, cytarabine administered intravenously at 1000 mg/m2, methotrexate sodium administered intravenously at 1 mg/m2, cyclophosphamide administered intravenously at 150 mg/m2, dexamethasone administered intravenously at 10 mg/m2, and mercaptopurine taken orally at 60 mg/m2.

    Additional oral medications include dexamethasone at 10 mg/m2 and methotrexate sodium at 20 mg/m2.

  3. Step 3

    <b>treatment path 2: standard of care chemotherapy</b>

    This path involves a standard set of chemotherapy medications.

    Medications administered intravenously include rituximab at 375 mg/m2, blinatumomab at 28 µg, cyclophosphamide at 500 mg/m2, idarubicin at 10 mg, dexamethasone at 40 mg, cytarabine at 60 mg/m2, asparaginase at 1000 U, crisantaspase at 50 mg/m2, doxorubicin at 50 mg/m2, and methotrexate sodium at 1 mg/m2.

    Medications taken orally include dexamethasone at 40 mg/m2, prednisone at 200 mg, prednisolone at 200 mg, mercaptopurine at 60 mg/m2, and methotrexate sodium at 20 mg.

    The medication vincristine sulfate is administered intravenously at a dose of 2 mg.

Who can join the trial?

12 criteria

  • You must give informed consent, which means you or your legal representative agrees to take part in the study after understanding all the details, before any study steps begin.
  • You must be 55 years of age or older.
  • You may be between 40 and 54 years of age if you have certain comorbidities, which are other medical conditions present at the same time as your leukemia, such as:
    • A history of severe pancreatitis (inflammation of the pancreas).
    • Diabetes mellitus that has caused damage to organs like the eyes, kidneys, or nerves.
    • Severe liver disease, such as cirrhosis (permanent scarring of the liver) with high pressure in the veins or a history of bleeding in the food pipe, accompanied by very high liver enzyme levels.
    • A body mass index (BMI) of 40 or higher combined with metabolic issues.
    • Other serious health conditions that make standard intensive chemotherapy too difficult to handle.
    • You must have a new diagnosis of Philadelphia-negative B-cell precursor acute lymphoblastic leukemia (ALL), which is a specific type of cancer found in the white blood cells.
    • Your ECOG performance status must be 2 or lower, which is a scale used to measure how well you can perform daily activities; a higher score may be allowed if it is caused by your leukemia.
    • Your kidney function must be adequate, measured by how well your kidneys filter waste from your blood.
    • Your liver function must be adequate, specifically looking at your total bilirubin levels, unless you have a specific harmless condition called Gilbert’s Disease or the cancer has spread to the liver.
    • Your heart function must be adequate, meaning your heart must pump blood effectively (measured by left ventricular ejection fraction) and you must not have uncontrolled or recent heart disease, such as a myocardial infarction (heart attack) or stroke within the last 3 months.

Who cannot join the trial?

10 criteria

  • You cannot participate if you have active CNS leukemia, which means cancer cells are currently present in your central nervous system (the brain and spinal cord), as confirmed by a lumbar puncture (a procedure where a needle is used to collect fluid from the spinal canal).
  • You cannot participate if you have had another type of malignancy (cancer) within the last 3 years, unless it was a specific type of skin, cervical, breast, or prostate cancer that was fully treated and is no longer active.
  • You cannot participate if you have CNS pathology, which refers to any medical conditions or damage affecting the brain or spinal cord, such as epilepsy (seizures), paresis (muscle weakness), aphasia (difficulty speaking or understanding language), stroke, dementia (memory loss and mental decline), or Parkinson's disease.
  • You cannot participate if you have a psychiatric condition (mental health disorder) that would prevent you from taking high doses of corticosteroids (strong anti-inflammatory medicines).
  • You cannot participate if you currently have or have a history of autoimmune disease (a condition where the immune system mistakenly attacks the body) that could affect the brain or spinal cord.
  • You cannot participate if you have a known infection with HIV (the virus that causes AIDS).
  • You cannot participate if you have an active or chronic infection of Hepatitis B or Hepatitis C (viruses that cause liver inflammation).
  • You cannot participate if you show any signs or symptoms of an acute infection (a sudden, severe infection) or an uncontrolled chronic infection (a long-term infection that is not being managed).
  • You cannot participate if you have already received cancer chemotherapy (drugs used to kill cancer cells) for this specific leukemia, unless it was IT chemotherapy (medicine injected directly into the spinal fluid) or specific preparation medicine.
  • You cannot participate if you are currently taking part in another study testing a new drug or medical device, or if you finished a different study less than 30 days ago.
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Investigated drugs

  • Blinatumomab

    is a type of immunotherapy that helps the body's own immune system find and destroy specific cancer cells.

  • Mercaptopurine

    is a chemotherapy medication used to prevent the growth of cancer cells.

  • Rituximab

    is a targeted therapy that attaches to certain proteins on the surface of cancer cells to help the immune system identify and attack them.

  • Cytarabine

    is a chemotherapy drug used to treat various types of blood cancers by preventing cancer cells from making new DNA.

  • Methotrexate

    is a chemotherapy medication that interferes with the growth of cancer cells by blocking certain nutrients they need to multiply.

  • Cyclophosphamide

    is a chemotherapy drug used to kill rapidly dividing cancer cells.

What is already known about the treatment

BLINATUMOMAB - This medication is administered through an intravenous infusion and is used to treat certain types of blood cancer. It belongs to a class of drugs known as bispecific T-cell engagers, which work by physically linking the patient's own immune cells to the cancer cells so the immune system can destroy them. It is currently a recognized treatment in medical literature for specific types of leukemia. CYCLOPHOSPHAMIDE - This drug is given via intravenous injection and is widely used in medicine to treat various types of cancer and autoimmune diseases. It is classified as an alkylating agent, which means it works by damaging the DNA inside cancer cells to prevent them from growing and multiplying. This mechanism helps stop the spread of the disease throughout the body. CYTARABINE - This medication is administered through an intravenous infusion and is a common treatment for several types of leukemia. It belongs to a group called antimetabolites, which work by mimicking the building blocks of DNA to interfere with the cancer cells' ability to copy their genetic material. By disrupting this process, the drug prevents the rapid division of cancer cells. DEXAMETHASONE - This medication can be taken orally or administered through an intravenous injection to reduce inflammation and treat certain cancers. It is a corticosteroid that works by altering the way the immune system responds, effectively calming overactive immune reactions. It is a well-established drug used extensively in both clinical practice and medical research. DOXORUBICIN - This drug is provided through an intravenous infusion and is used as a chemotherapy treatment for many different types of cancer. It is classified as an antitumor antibiotic that works by interfering with the DNA and RNA processes within cancer cells. This action prevents the cells from functioning and replicating correctly. IDARUBICIN - This medication is administered intravenously and is primarily used in the treatment of acute myeloid leukemia. It belongs to the anthracycline class of chemotherapy, which works by inserting itself into the DNA of cancer cells to prevent them from multiplying. It is a standard component in many established cancer treatment protocols. MERCAPTOPURINE - This drug is taken orally and is frequently used to treat various types of leukemia and certain immune system disorders. It is classified as an antimetabolite, which works by mimicking naturally occurring substances in the body to disrupt the production of DNA in cancer cells. This interference effectively slows down the growth of the diseased cells. METHOTREXATE SODIUM - This medication is administered either orally or through an intravenous infusion to treat cancer and inflammatory conditions. It belongs to a group called antimetabolites, which work by blocking a specific enzyme that cells need to produce the building blocks for DNA. This prevents cancer cells from being able to grow and divide. PEGASPARGASE - This drug is given through an intravenous injection and is used in the treatment of certain blood cancers. It is an enzyme-based therapy that works by depriving cancer cells of a vital amino acid called asparagine, which they need to survive. By depleting this nutrient, the drug helps to starve and kill the cancer cells. PREDNISONE - This medication is taken orally and is used to treat a wide range of conditions, including inflammation and certain cancers. It is a corticosteroid that works by suppressing the body's immune response and reducing swelling and irritation. It is a very common and well-known medication in medical practice. PREDNISOLONE - This drug is administered orally and is used to manage inflammation and various immune-related disorders. Like other corticosteroids, it works by modifying the immune system's activity to decrease harmful inflammatory responses. It is widely recognized and used in clinical settings globally. RITUXIMAB - This medication is given through an intravenous infusion and is used to treat various types of B-cell cancers and autoimmune diseases. It belongs to a class of drugs called monoclonal antibodies, which work by attaching to a specific protein on the surface of B-cells to signal the immune system to destroy them. It is a standard and highly effective treatment in modern oncology. VINCRISTINE SULFATE - This drug is administered through an intravenous injection and is used to treat several types of cancer, including leukemia. It is classified as a vinca alkaloid, which works by interfering with the cell's ability to divide by disrupting the tiny structures that move chromosomes during cell division. This effectively stops cancer cells from multiplying.

Investigated diseases

B-cell precursor Acute Lymphoblastic Leukemia - This is a type of cancer that affects the white blood cells, specifically the immature cells known as precursors. These abnormal cells accumulate in the bone marrow and blood, interfering with the production of normal blood cells. The disease can progress by spreading from the bone marrow to other parts of the body, such as the lymph nodes, spleen, or liver. It is characterized by the rapid multiplication of these cancerous cells.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503640-14-00Protocol code20190360Estimated enrolment306 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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