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Study on Imatinib and Chemotherapy Combination for Children with 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 testing a medication called imatinib, which is used in combination with different chemotherapy treatments. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. The purpose of this study is to compare how well patients with Ph+ ALL respond to imatinib when it is combined with two different chemotherapy treatment plans.

Participants in the study will receive imatinib along with one of two chemotherapy regimens. These regimens include various medications such as tioguanine, imatinib, doxorubicin hydrochloride, pegaspargase, cytarabine, dexamethasone, prednisone, mercaptopurine, crisantaspase, daunorubicin hydrochloride, ifosfamide, methotrexate, cyclophosphamide, etoposide, vincristine sulfate, and hydrocortisone sodium succinate. Some of these medications are given as tablets, while others are administered through injections or infusions. The study will monitor the participants over a period to see how well the treatment works in preventing the cancer from coming back or worsening.

The trial aims to improve the understanding of how effective imatinib is when used with different chemotherapy combinations in treating Ph+ ALL. Participants will be closely monitored throughout the study to ensure their safety and to gather information on the effectiveness of the treatment. The study will help determine the best treatment approach for patients with this specific type of leukemia.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the clinical trial, you will be officially enrolled. This involves confirming your eligibility based on specific criteria, such as age and medical condition. You must be between 1 and 21 years old and have a new diagnosis of acute lymphoblastic leukemia (ALL) with specific genetic markers.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your health status. This includes checking your liver, heart, and kidney functions to ensure they are adequate for participation in the trial.

  3. Step 3

    Treatment phase

    You will begin the treatment phase, which involves receiving a combination of medications. The main medication used is imatinib, which you may have already started before joining the trial. You will also receive other chemotherapy drugs, which may include vincristine, dexamethasone, and pegaspargase, among others.

    The medications will be administered in various forms, such as oral tablets or injections. The frequency and dosage will be determined by the trial protocol and your specific treatment plan.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health and response to the treatment will be closely monitored. Regular follow-up visits will be scheduled to assess your progress and manage any side effects.

    The primary goal is to evaluate your disease-free survival, which means the time you remain free from leukemia after treatment.

  5. Step 5

    Completion

    The trial is expected to continue until January 31, 2027. Upon completion, your overall health and treatment outcomes will be reviewed. This information will contribute to understanding the effectiveness of the treatment regimen.

Who can join the trial?

12 criteria

  • Patients must be enrolled in a National ALL protocol before joining this study. Diagnostic samples must be available for testing.
  • Patients must be older than 1 year and younger than 21 years at the time of their ALL diagnosis.
  • Patients must have a new diagnosis of acute lymphoblastic leukemia (ALL), which can be type B, type T, or mixed phenotypic acute leukemia (MPAL) with clear evidence of BCR-ABL1 fusion (a specific genetic change) confirmed by tests like karyotype, FISH, or RT-PCR.
  • For patients with BCR-ABL1 fusion:
    • They must have started induction therapy, which includes drugs like vincristine, a corticosteroid, usually PEG-L-Asparaginase, and possibly anthracycline or other standard chemotherapy drugs.
    • They must not have received more than 14 days of this multi-drug induction therapy starting from the first dose of vincristine.
    • They may have started taking imatinib (a medication) before joining the study but not for more than 14 days.
    • For patients with ABL-class fusion:
      • They must have completed 4 or 5 weeks of multi-drug induction chemotherapy.
      • They may have started taking imatinib during the induction phase, at the same time or after the first dose of vincristine.
      • Patients must have a performance status that matches ECOG scores of 0, 1, or 2, which indicates their ability to perform daily activities.
      • Patients must have adequate liver function.
      • Patients must have adequate heart function.
      • Patients must have adequate kidney function.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides Acute Lymphoblastic Leukemia cannot participate. Acute Lymphoblastic Leukemia is a type of blood cancer.
  • Patients who have had a previous treatment for their leukemia that is not part of this study are not eligible.
  • Patients with severe heart problems cannot join the study. This includes conditions like heart failure or a recent heart attack.
  • Patients with uncontrolled infections, meaning infections that are not being successfully treated, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have a known allergy to the study medication or similar drugs are not eligible.
  • Patients who are unable to follow the study procedures or attend the required visits are excluded.
  • Patients with a history of non-compliance with medical treatments are not eligible.
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Investigated drugs

  • Imatinib

    is a medication used in this clinical trial to treat a type of blood cancer called Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It works by blocking the action of a protein that causes cancer cells to grow. By doing this, imatinib helps to stop the spread of cancer cells and can lead to a reduction in the number of cancer cells in the body. In this trial, imatinib is being tested in combination with other chemotherapy treatments to see if it can improve the chances of staying cancer-free for longer periods.

  • COG ALL Chemotherapy Backbone

    is a treatment plan that includes a combination of different chemotherapy drugs. These drugs work together to kill cancer cells or stop them from growing. The COG ALL chemotherapy backbone is designed for patients with a standard risk of Ph+ ALL and is used in this trial to see how well it works when combined with imatinib.

  • EsPhALL Chemotherapy Backbone

    is another treatment plan that involves a more intensive combination of chemotherapy drugs. Like the COG ALL chemotherapy backbone, it aims to destroy cancer cells or prevent them from multiplying. This treatment is used for patients with a higher risk of Ph+ ALL. In the trial, researchers are testing how effective this intensive chemotherapy is when used alongside imatinib, compared to the standard COG ALL chemotherapy backbone.

What is already known about the treatment

Imatinib – Imatinib is administered orally in the form of a tablet and is currently well-established in medical literature as a treatment for certain types of leukemia. It is primarily used for treating Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). At the molecular level, imatinib works by blocking a specific protein that promotes the growth of cancer cells, thereby inhibiting their proliferation. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Acute lymphoblastic leukemia – Acute lymphoblastic leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as lymphoblasts. These abnormal cells crowd out normal cells, leading to symptoms such as fatigue, easy bruising, and increased risk of infections. The disease progresses rapidly, requiring prompt medical attention. As the condition advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression involves a series of stages where the number of abnormal cells increases, further impairing the body's ability to function normally.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515499-12-00Protocol codeEsPhALL2017/COGAALL1Estimated enrolment306 patientsSponsorUniversita Degli Studi Di Milano Bicocca

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).