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Study of dasatinib treatment in children and adolescents with Philadelphia chromosome-positive leukemia who cannot take imatinib or for whom imatinib is not effective

Verified siteInvestigationalNo 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 and adolescents with Chronic Myeloid Leukemia (CML) and Philadelphia chromosome-positive (Ph+) leukemias who either have newly diagnosed disease or have not responded well to treatment with imatinib. The study will test a medication called dasatinib (also known as Sprycel), which is available as both tablets and as a powder that can be made into a liquid for drinking.

The main purpose is to determine how well dasatinib works in young patients whose leukemia has either become resistant to imatinib treatment or who cannot tolerate imatinib's side effects. The study will also look at how dasatinib works in patients who have just been diagnosed with CML. Resistance means the cancer continues to grow despite treatment, while intolerance means experiencing severe side effects that prevent continuing the medication.

During the study, participants will receive dasatinib treatment, and doctors will monitor how their disease responds to the medication. The study will track several important measures of treatment success, including how well the medication controls blood cell counts and whether it reduces or eliminates cancer cells that contain the Philadelphia chromosome, a specific genetic change found in these types of leukemia.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and group assignment

    You will be assigned to one of three groups (cohorts) based on your condition:

    Cohort 1: Patients with chronic phase CML who cannot take imatinib

    Cohort 2: Patients with Ph+ ALL or advanced phases of CML who cannot take imatinib

    Cohort 3: Newly diagnosed patients with chronic phase CML

  2. Step 2

    Medical examination

    Your doctor will perform tests to check your blood cell counts

    Your bone marrow will be examined to confirm diagnosis

    Additional tests will check your liver and kidney function

  3. Step 3

    Treatment initiation

    You will receive dasatinib treatment

    The medication comes as film-coated tablets or oral solution

    You will take the medication by mouth as prescribed by your doctor

  4. Step 4

    Regular monitoring

    Your blood counts will be checked regularly

    Bone marrow examinations will be performed to measure treatment response

    Your doctor will monitor for any side effects

  5. Step 5

    Response evaluation

    Your doctor will measure how well the treatment is working by checking:

    Blood cell counts returning to normal levels (Complete Hematologic Response)

    Reduction in abnormal cells in bone marrow (Major Cytogenetic Response)

    These evaluations will continue throughout the study period

  6. Step 6

    Long-term follow-up

    Your progress will be monitored for disease control

    Regular check-ups will continue to ensure the treatment remains effective

    The study will track your long-term health outcomes

Who can join the trial?

15 criteria

  • Patient must provide signed written informed consent
  • Age between 1 to 18 years (both males and females can participate)
  • Women who can become pregnant must use two methods of contraception during the study and for 1 month after the last dose
  • Patients must belong to one of these groups:
    • Group 1: Patients with chronic phase CML who did not respond to or cannot tolerate Imatinib treatment
    • Group 2: Patients with Ph+ ALL (a type of blood cancer) or advanced phase CML who did not respond to or cannot tolerate Imatinib treatment
    • Group 3: Patients newly diagnosed with chronic phase CML
    • Patient must have a Lansky or Karnofsky score above 50 (scales that measure ability to perform daily activities)
    • Life expectancy must be at least 12 weeks
    • Patient must have recovered from side effects of previous treatments (except hair loss) to normal levels or mild symptoms
    • Blood tests must show adequate levels of:
      • Sodium
      • Bicarbonate
      • Phosphate
      • Calcium
      • Liver function
      • Kidney function

Who cannot join the trial?

14 criteria

  • Prior treatment with any BCR-ABL inhibitor other than imatinib (a medication used to treat certain types of blood cancer)
  • Known presence of the T315I mutation (a specific genetic change that makes the cancer resistant to certain treatments)
  • Active central nervous system involvement by leukemia
  • Significant heart problems, including:
    • Uncontrolled or severe heart disease
    • Heart attack within 6 months
    • Unstable heart rhythm disorders
    • Severe liver problems (impaired liver function)
    • Severe kidney problems (impaired kidney function)
    • Active uncontrolled infections requiring treatment
    • Pregnancy or breastfeeding
    • Unable to take oral medications
    • Any serious medical condition that could interfere with study participation
    • Current participation in another clinical trial with investigational drugs
    • Known allergic reaction to the study medication or similar compounds
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Investigated drugs

  • Dasatinib

    is a medication used to treat certain types of blood cancers. It works by blocking specific proteins that cause cancer cells to grow and divide. This medication is specifically designed for patients whose cancer has become resistant to other treatments or who cannot tolerate them.

  • Imatinib

    is a cancer medication that was previously used in the treatment of these patients. It works similarly to dasatinib by targeting specific proteins in cancer cells. In this trial, dasatinib is being studied as an alternative treatment for patients who did not respond well to imatinib or couldn't tolerate its side effects.

What is already known about the treatment

  • Dasatinib

    An oral targeted therapy medication used in the treatment of Philadelphia chromosome-positive (Ph+) leukemias, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), particularly in cases where patients have shown resistance or intolerance to imatinib therapy. This tyrosine kinase inhibitor works by blocking specific proteins that promote cancer cell growth, effectively slowing or stopping the progression of leukemia cells. The medication belongs to the class of protein kinase inhibitors and has shown significant effectiveness in treating both adult and pediatric patients, with clinical trials demonstrating its value as a second-line treatment option.

  • Imatinib

    An oral chemotherapy medication that serves as a first-line treatment for Philadelphia chromosome-positive (Ph+) leukemias, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). This targeted therapy works by blocking specific proteins called tyrosine kinases that are responsible for the growth of cancer cells, helping to control the progression of the disease. As a member of the tyrosine kinase inhibitor class, imatinib has revolutionized the treatment of CML and other Ph+ leukemias, though some patients may develop resistance or intolerance to the medication over time.

Investigated diseases

  • Chronic Myeloid Leukemia (CML)

    A type of blood cancer that begins in the bone marrow and causes the body to produce too many white blood cells. The disease typically progresses through three phases: chronic phase, accelerated phase, and blast phase. In the chronic phase, patients may have mild symptoms or no symptoms at all. The disease develops when a genetic change occurs in blood stem cells, creating an abnormal gene called the Philadelphia chromosome.

  • Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL)

    A fast-growing cancer of lymphoid blood cells characterized by the presence of an abnormal Philadelphia chromosome. The disease causes the bone marrow to produce too many immature lymphocytes (a type of white blood cell). These abnormal cells accumulate in the bone marrow, preventing the production of normal blood cells. The condition primarily affects blood and bone marrow.

  • Blast Phase CML (BP-CML)

    An advanced phase of Chronic Myeloid Leukemia where immature blood cells (blasts) multiply rapidly in the bone marrow and blood. During this phase, more than 20% of the cells in the blood or bone marrow are blast cells. The condition results in decreased production of healthy blood cells.

  • Accelerated Phase CML (AP-CML)

    A transitional phase of Chronic Myeloid Leukemia between the chronic and blast phases. During this phase, the number of immature blood cells increases in the bone marrow and blood. The disease shows signs of progression with an increase in blast cells, though not as high as in the blast phase.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2024-510784-36-00Protocol codeCA180-226Estimated enrolment149 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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