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Study of asciminib, dexamethasone, blinatumomab, and vincristine sulfate in children and young adults with relapsed or refractory Philadelphia chromosome-positive 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 treating children, adolescents, and young adults with Acute Lymphoblastic Leukemia, which is a type of cancer that affects the blood and bone marrow. The research specifically targets patients with certain genetic markers, known as BCR::ABL1-positive or Ph-like, where the cancer cells have specific changes in their DNA. This study is for patients whose disease has either returned after previous treatment, which is called relapsed, or has not responded to initial treatments, which is called refractory.

The purpose of the study is to evaluate the safety and effectiveness of a combination of treatments. The experimental treatment includes the drug asciminib, which is taken by mouth, alongside chemotherapy, a type of treatment using strong medicines to kill cancer cells. Following this, the drug blinatumomab, which is given through an IV infusion, may be used. Other medications that may be part of the background care include vincristine sulfate, dexamethasone, cytarabine, methotrexate, hydrocortisone, and prednisolone acetate.

The study is divided into different stages to find the most appropriate dose of the medicine. In the first stage, researchers look at how the body reacts to different amounts of the drug to ensure safety. In the second stage, the focus shifts to determining how many patients achieve complete remission, a state where all signs of cancer have disappeared. Throughout the process, doctors will monitor for any side effects or changes in health to ensure the treatment is managed carefully.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive asciminib, which is taken as oral granules.

    This medication is used alongside chemotherapy, which is a type of treatment using drugs to kill cancer cells.

    During this phase, you may also receive medications through an intrathecal route, which means the medicine is injected into the space around the spinal cord to reach the central nervous system.

    The intrathecal medications used as background therapy include hydrocortisone, prednisolone acetate, cytarabine, and methotrexate.

  2. Step 2

    Follow-up treatment phase

    Following the initial treatment, you will receive blinatumomab via intravenous (iv) infusion, which is a method of delivering medicine directly into a vein.

    You may also receive other medications via intravenous (iv) infusion, such as vincristine sulfate and dexamethasone sodium phosphate.

    Additional medications may be administered orally, such as dexamethasone.

Who can join the trial?

10 criteria

  • Both males and females can join the study.
  • Participants must be at least 1 year old and no older than 30 years old at the time of the initial screening.
  • Participants must have a documented history of Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL) or Philadelphia-like (Ph-like) ALL, which are specific types of blood cancer.
  • The cancer must involve specific genetic changes known as ABL1 or ABL2 rearrangements, which means certain parts of the DNA have changed or moved.
  • Participants with a specific genetic mutation called T315I are allowed to join.
  • The study is for patients with active B-Cell ALL, a type of cancer affecting white blood cells, where the cancer cells (called blasts) are measurable through specific blood or bone marrow tests.
  • The cancer must be either primary refractory, meaning it did not respond to the initial treatment, or relapsed, meaning the cancer has returned after previous treatment.
  • Participants can have cancer that has spread to the central nervous system (CNS), which includes the brain and spinal cord, at different levels of severity labeled as CNS1, CNS2, CNS3a, or CNS3b.
  • The cancer must show the presence of a marker called CD19 on the surface of the cancer cells, which can be checked in the blood or bone marrow (the soft tissue inside bones where blood cells are made).
  • If a patient previously received treatments that target the CD19 marker, such as CAR T cell therapy or blinatumomab, they must still have CD19 expressing cells present after finishing those treatments.

Who cannot join the trial?

6 criteria

  • You cannot participate if you have had more than three relapses of acute lymphoblastic leukemia (ALL), which is a type of cancer that affects the white blood cells.
  • You are not eligible if you have extramedullary disease, which means the cancer has spread outside of the bone marrow to other parts of the body, such as the central nervous system (CNS), which is the brain and spinal cord.
  • You cannot join if you show signs of CNS3c, which means the cancer is actively affecting the central nervous system (CNS) through physical signs like facial nerve weakness, issues with the brain or eyes, or hypothalamic syndrome, a condition affecting the part of the brain that controls hormones and body functions.
  • You are excluded if you have had a hematopoietic stem cell transplant, a procedure where healthy blood-forming cells are put into the body, within the last 12 weeks.
  • You cannot participate if you have active graft-versus-host disease (GVHD), which is a condition where transplanted immune cells attack the recipient's body, whether it is acute (happening suddenly) or chronic (happening over a long period).
  • You are not eligible if you have received any medication to treat or prevent graft-versus-host disease (GVHD) within the last 4 weeks.
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Investigated drugs

  • Asciminib

    is a medication taken by mouth that is being tested to see how well it works in treating specific types of leukemia.

  • Dexamethasone

    is a steroid medication that can be taken by mouth or given through an IV infusion to help treat the condition.

  • Blinatumomab

    is a therapy given through an IV infusion that helps the body's immune system target and fight leukemia cells.

  • Vincristine

    is a chemotherapy medication given through an IV infusion to help kill cancer cells.

What is already known about the treatment

  • Asciminib hydrochloride

    This medication is taken orally in the form of film-coated granules and is currently used as a specialized treatment for certain types of blood cancer. It works by targeting and blocking a specific protein called BCR::ABL1 that helps cancer cells grow and survive. As a targeted therapy, it is classified as a tyrosine kinase inhibitor designed to stop the signals that drive leukemia.

  • Blinatumomab

    This drug is administered through a continuous intravenous infusion and is an established treatment for specific types of leukemia. It works by acting as a bridge, physically linking the body's own immune cells to the cancer cells so the immune system can find and destroy them. It belongs to a class of medications known as bispecific T-cell engagers.

  • Dexamethasone

    This medication can be taken orally or given through an intravenous infusion to reduce swelling and inflammation in the body. It is widely used in medical practice to manage various conditions, including treating side effects during cancer therapy. It belongs to a group of drugs called corticosteroids that work by suppressing the body's immune response.

  • Dexamethasone sodium phosphate

    This version of the medication is administered via intravenous infusion to quickly manage inflammation and swelling. It is a standard part of many medical treatments used to control the body's immune reaction. It is classified as a corticosteroid that works at a molecular level to dampen inflammatory signals.

  • Vincristine sulfate

    This medication is delivered through an intravenous infusion and is a well-known component of many cancer treatment plans. It works by stopping cancer cells from dividing, which prevents them from multiplying and spreading. It is classified as a chemotherapy drug known as a vinca alkaloid.

Investigated diseases

Relapsed or refractory BCR::ABL1-positive or BCR::ABL1-like acute lymphoblastic leukemia - This is a type of cancer that affects the white blood cells in the bone marrow and blood. It occurs when the disease returns after initial treatment or when it does not respond to standard therapies. The condition is characterized by specific genetic changes, such as the presence of a particular protein or a similar genetic pattern. As the disease progresses, abnormal white blood cells multiply rapidly and crowd out healthy blood cells. This accumulation interferes with the normal production of essential blood components.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-522019-40-00Protocol codeCABL001L12101Estimated enrolment49 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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