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Study of Dasatinib and Venetoclax for Children with Relapsed or Refractory Leukemia or Lymphoma with MAPK/SRC Pathway Mutation

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 clinical trial is focused on studying certain types of blood cancers in children, specifically Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. These conditions are being examined when they have returned after treatment or have not responded to treatment. The study involves two medications: Venetoclax, also known by its code name ABT-199, and Dasatinib. Venetoclax is available as an oral suspension and film-coated tablets, while Dasatinib is available as film-coated tablets and powder for oral suspension. Both medications are designed to target cancer cells and are classified as anti-neoplastic agents, which means they work to stop the growth of cancer cells.

The purpose of this study is to explore the safety and effectiveness of these medications in children with specific genetic changes in their cancer cells. These changes are related to the MAPK/SRC signaling pathway, which is a series of interactions between proteins in a cell that can lead to cancer growth. The study is divided into two phases. The first phase aims to determine the safest dose of the medications, while the second phase evaluates how well the medications work in treating the cancer. Participants will receive either Venetoclax or Dasatinib, or a combination of both, and their health will be monitored closely throughout the study.

During the trial, participants will take the medications orally, either as a liquid or a tablet, depending on the formulation. The study will track various outcomes, such as the overall response to the treatment and the time it takes for the cancer to return, if it does. The trial will also assess the quality of life of participants using a specific questionnaire designed for children with cancer. The study is expected to continue until 2031, with recruitment starting in 2024.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to evaluate eligibility. This includes reviewing medical history and current health status.

    A series of tests may be performed to confirm the presence of specific genetic mutations related to the study.

  2. Step 2

    Treatment phase 1

    The first phase of treatment involves taking the medication venetoclax orally. The dosage and frequency will be determined by the study team based on individual needs.

    Regular monitoring is conducted to assess the body's response to the medication and to ensure safety.

  3. Step 3

    Treatment phase 2

    In the second phase, the medication dasatinib is introduced. This is also taken orally, with the dosage adjusted as necessary.

    Continued monitoring is essential to evaluate the effectiveness of the treatment and to manage any side effects.

  4. Step 4

    Follow-up assessments

    Throughout the trial, regular follow-up assessments are scheduled. These include physical exams, blood tests, and other necessary evaluations.

    The purpose of these assessments is to track progress and make any needed adjustments to the treatment plan.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is conducted to determine the overall response to the medications.

    This evaluation helps in understanding the effectiveness of the treatment and planning any further necessary medical care.

Who can join the trial?

8 criteria

  • Children between 1 year (at least 12 months old) and 18 years of age at the time of first diagnosis, and less than 21 years at the time of joining the study.
  • Performance status: For patients older than 12 years, a Karnofsky performance status of at least 50%. For patients 12 years or younger, a Lansky Play score of at least 50%. These scores measure the patient's ability to perform daily activities.
  • Written informed consent from parents or legal representatives, and the patient, along with age-appropriate agreement from the child, must be obtained before any study-specific procedures are conducted.
  • Patients must be able to comfortably swallow capsules for all oral medications, unless an oral solution is available or tablets can be dissolved. If necessary, medication can be given through a feeding tube.
  • Patients must have had advanced testing of their disease using molecular profiling and flow-cytometric analysis before joining the trial. This helps understand the specific characteristics of the disease. Additional drug response profiling and methylation testing is recommended but not required.
  • Patients whose tumor shows specific genetic changes, such as NUP214-ABL1 fusion or other ABL1 fusion, activating the kinase domain, or ABL1 amplification, or PDGFRβ-fusion with various partners, or patients with a very low dasatinib IC50 value (a measure of drug effectiveness) in specific tests.
  • Adequate organ function:
    • Renal and hepatic function: Serum creatinine should be no more than 1.5 times the upper limit of normal for age, or creatinine clearance should be at least 60 mL/min/1.73 m². Direct bilirubin should be no more than 2 times the upper limit of normal (or 3 times for patients with Gilbert's syndrome). ALT/SGPT and AST/SGOT should be no more than 5 times the upper limit of normal. Patients with liver issues related to their disease may still be eligible after discussion with the sponsor.
    • Cardiac function: Shortening fraction should be more than 29% (or more than 35% for children under 3 years), and/or left ventricular ejection fraction should be at least 50%, as determined by heart tests. There should be no significant heart rhythm problems.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not related to the study.
  • Patients who have had a severe allergic reaction to similar treatments in the past.
  • Patients who are currently pregnant or breastfeeding.
  • Patients with severe heart problems.
  • Patients with uncontrolled infections.
  • Patients who have received another experimental treatment within the last 4 weeks.
  • Patients with a history of drug or alcohol abuse that could interfere with the study.
  • Patients who are unable to follow the study procedures for any reason.
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Investigated drugs

  • Investigational Agent 1

    is a new type of medication being tested to see if it is safe and can be tolerated by patients. It is designed to target specific changes in the cells of children with certain blood cancers that have come back or are not responding to treatment. The goal is to find out if this medication can help stop the cancer cells from growing.

  • Investigational Agent 2

    is another new medication being studied in this trial. It works by focusing on particular genetic changes in the cancer cells of children with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Researchers want to see if this medication can effectively slow down or stop the growth of these cancer cells.

What is already known about the treatment

Investigational Agent – This medication is currently being studied in clinical trials and is not yet approved for general medical use. It is administered to patients in a controlled clinical setting, typically through intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The main focus of this trial is to determine the safety and appropriate dosage of the medication, as well as to evaluate its effectiveness in treating specific types of blood cancers in children, such as acute lymphoblastic leukemia and lymphoblastic lymphoma, especially in cases where the disease has returned or is resistant to other treatments. The medication works by targeting specific molecular changes in cancer cells, aiming to stop their growth and spread. It falls under the category of targeted cancer therapies, which are designed to interfere with cancer cell growth at the molecular level.

Investigated diseases

  • Acute Lymphoblastic Leukemia

    This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells, known as lymphoblasts. It progresses rapidly, leading to an accumulation of these cells in the bone marrow, which interferes with the production of normal blood cells. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. Symptoms may include fatigue, fever, frequent infections, and easy bruising or bleeding. The disease is most common in children but can also occur in adults.

  • Lymphoblastic Lymphoma

    This is a rare type of non-Hodgkin lymphoma that primarily affects the lymphatic system, which is part of the immune system. It is characterized by the rapid growth of immature lymphocytes, which are a type of white blood cell. The disease can present as a mass in the chest, neck, or other areas of the body, and may cause symptoms such as swelling, difficulty breathing, or chest pain. As it progresses, it can spread to the bone marrow and other organs. Lymphoblastic lymphoma is closely related to acute lymphoblastic leukemia and shares many clinical features.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501866-22-00Protocol codeHEM-iSMART - Sub BEstimated enrolment25 patientsSponsorPrincess Maxima Center For Pediatric Oncology

sourced from the EU Clinical Trials Register and site verification

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