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Study Comparing Ponatinib and Imatinib with Chemotherapy for Patients with Newly Diagnosed Philadelphia Chromosome-Positive 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 clinical trial is focused on studying a type of blood cancer called Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). The study is comparing two treatments: Ponatinib (AP24534; Iclusig) and Imatinib, both of which are medications taken as film-coated tablets. These treatments are being tested in combination with a type of chemotherapy that is less intense than usual. The purpose of the study is to see how effective these treatments are when used as the first line of therapy for patients who have been newly diagnosed with Ph+ ALL.

Participants in the study will be randomly assigned to receive either Ponatinib or Imatinib, along with the reduced-intensity chemotherapy. The study will observe the participants over a period of time to assess the effectiveness of the treatments. The main goal is to determine how well the treatments work in achieving a state where no cancer cells can be detected in the blood or bone marrow, which is known as a complete remission. The study will also look at other outcomes, such as the duration of remission and overall survival of the participants.

The trial is designed to provide valuable information about the potential benefits and safety of using Ponatinib or Imatinib in treating Ph+ ALL. By comparing these two treatments, researchers hope to find the most effective approach for managing this type of leukemia. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatments.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is randomly assigned to receive either ponatinib or imatinib in combination with reduced-intensity chemotherapy. These medications are administered orally in the form of film-coated tablets.

  2. Step 2

    Medication administration

    The patient takes the assigned medication, either ponatinib or imatinib, as part of their treatment regimen. The specific dosage and frequency are determined by the study protocol and the patient's individual treatment plan.

  3. Step 3

    Induction phase

    During the induction phase, the patient receives the medication in combination with reduced-intensity chemotherapy. The goal is to achieve a complete remission (CR), which means no detectable cancer cells in the blood or bone marrow.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient's response to treatment is closely monitored. This includes regular blood tests and other assessments to evaluate the effectiveness of the medication and to check for any side effects.

  5. Step 5

    End of induction evaluation

    At the end of the induction phase, the patient's response is evaluated to determine if they have achieved a complete remission (CR) or minimal residual disease-negative complete remission (MRD-negative CR).

  6. Step 6

    Continuation or adjustment of treatment

    Based on the evaluation results, the treatment plan may be continued or adjusted. If the patient achieves CR or MRD-negative CR, the treatment may continue as planned. If not, adjustments may be made to improve outcomes.

  7. Step 7

    Follow-up

    After the treatment phase, the patient enters a follow-up period where their health and any long-term effects of the treatment are monitored. This helps in understanding the overall effectiveness and safety of the treatment.

Who can join the trial?

16 criteria

  • Male or female patients aged 18 years or older.
  • Newly diagnosed with a specific type of leukemia called **Ph+ ALL** or **BCR-ABL1 positive ALL**.
  • Have a performance status of **2 or less** on a scale used to assess how well a patient can perform daily activities.
  • Meet certain laboratory test values within 30 days before starting the study:
    • Total serum bilirubin should be **1.5 times or less** the upper limit of normal, unless due to a condition called **Gilbert's syndrome**.
    • Levels of liver enzymes called **ALT** or **AST** should be **2.5 times or less** the upper limit of normal.
    • Serum creatinine should be **1.5 times or less** the upper limit of normal, and the ability of the kidneys to filter blood should be **30 mL/minute or more**.
    • Serum lipase should be **less than 1.5 times** the upper limit of normal.
    • Have a normal **QT interval**, which is a measure of heart rhythm, on an electrocardiogram.
    • Female patients must meet one of the following:
      • Be postmenopausal for at least 1 year.
      • Be surgically sterile.
      • If able to have children, agree to use one highly effective method of birth control and one additional effective method at the same time.
      • Agree to practice true abstinence if it aligns with their lifestyle.
      • Male patients must meet one of the following:
        • Agree to use effective barrier contraception during the study and for 120 days after the last dose.
        • Agree to practice true abstinence if it aligns with their lifestyle.
        • Provide voluntary written consent before any study-related procedures that are not part of standard medical care.
        • Be willing and able to attend scheduled visits and follow study procedures.

Who cannot join the trial?

6 criteria

  • Patients who have not been newly diagnosed with **Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)** cannot participate. This is a specific type of blood cancer.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to receive the specific treatments being tested in the study cannot participate. These treatments include **ponatinib** and **imatinib**, which are medications used to treat certain types of leukemia.
  • Patients who have other medical conditions that might interfere with the study treatments or outcomes cannot participate. This ensures the safety and accuracy of the study results.
  • Patients who are unable to follow the study procedures or attend required visits cannot participate. This is important for collecting accurate data.
  • Patients who are part of a vulnerable population that the study cannot safely include cannot participate. This is to protect individuals who might be at higher risk.
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Investigated drugs

  • Ponatinib

    is a medication used in this study to treat patients with a specific type of leukemia known as Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It is being tested to see how effective it is when combined with a less intense form of chemotherapy. The goal is to determine if it can help achieve a state where no minimal residual disease (MRD) is detected, which means that no cancer cells are found in the bone marrow after treatment.

  • Imatinib

    is another medication being used in this study for the same type of leukemia, Ph+ ALL. Like ponatinib, it is combined with reduced-intensity chemotherapy to see how well it works as a first-line treatment. The study aims to compare its effectiveness to ponatinib in achieving MRD-negative complete remission, which indicates that the leukemia is in remission and no cancer cells are detectable.

What is already known about the treatment

  • Ponatinib

    Ponatinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating newly diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). The medication works by inhibiting specific proteins that promote cancer cell growth, particularly targeting the BCR-ABL protein. It is classified as a tyrosine kinase inhibitor, which helps to block the signals that cause cancer cells to multiply.

  • Imatinib

    Imatinib is also taken orally in tablet form. It is a well-established medication in the treatment of various types of leukemia, including Ph+ ALL, and is widely documented in medical literature. Imatinib functions by blocking the BCR-ABL protein, which is responsible for the uncontrolled growth of cancer cells. It belongs to the pharmacological class of tyrosine kinase inhibitors, which are designed to interfere with the signaling pathways that lead to cancer cell proliferation.

Investigated diseases

Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) – This is a type of cancer that affects the blood and bone marrow, characterized by the presence of the Philadelphia chromosome. It is a subtype of acute lymphoblastic leukemia, which progresses rapidly and requires immediate treatment. The disease involves the overproduction of immature white blood cells, known as lymphoblasts, which crowd out normal cells in the bone marrow. This can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The presence of the Philadelphia chromosome is due to a genetic abnormality that results in the production of an abnormal protein promoting the growth of cancer cells. The progression of Ph+ ALL can vary, but it typically involves a rapid increase in the number of immature white blood cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508463-71-00Protocol codePonatinib-3001Estimated enrolment258 patientsSponsorTakeda Development Center Americas Inc.

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