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Study of Ponatinib and Chemotherapy for Adults with Philadelphia Chromosome-Negative 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 treating a specific type of leukemia called Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia (ALL), particularly a subtype known as BCR/ABL1-like ALL. The study involves using a medication called Ponatinib, which is a type of drug known as a tyrosine kinase inhibitor, in combination with various chemotherapy drugs. The chemotherapy drugs used in this study include Dexamethasone Disodium Phosphate, Vincristine Sulfate, Mercaptopurine, Filgrastim, Idarubicin Hydrochloride, Lenograstim, Prednisone, Cyclophosphamide, Cytarabine, Folinic Acid, Methotrexate, and Methylprednisolone Sodium Succinate. Some patients may receive a placebo as part of the study.

The purpose of the study is to see how well this combination of treatments works in helping patients achieve remission, which means the disease is no longer detectable, even at a very detailed level. The study will follow patients over a period of time to monitor their response to the treatment. Participants will receive the treatment in cycles, and their health will be closely monitored throughout the study to assess the effectiveness and safety of the treatment.

During the study, patients will receive the treatment through different methods, such as oral tablets or injections, depending on the specific medication. The study aims to improve the percentage of patients who achieve remission and to understand the long-term outcomes of using Ponatinib with chemotherapy. The study will also track any side effects or adverse events that may occur during the treatment. The overall goal is to find a more effective treatment approach for patients with this 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

    Initial treatment phase

    Begin taking ponatinib in the form of 15 mg film-coated tablets. This medication is taken orally.

    Receive dexamethasone disodium phosphate through an intravenous route.

    Administer vincristine sulfate via intravenous infusion.

    Take mercaptopurine orally.

  2. Step 2

    Supportive care phase

    Receive filgrastim through a subcutaneous injection to support white blood cell production.

    Administer idarubicin hydrochloride intravenously.

    Receive lenograstim via subcutaneous injection.

  3. Step 3

    Consolidation treatment phase

    Take prednisone orally.

    Receive cyclophosphamide intravenously.

    Administer cytarabine either intravenously or subcutaneously.

  4. Step 4

    Maintenance treatment phase

    Receive folinic acid through intravenous infusion.

    Administer methotrexate intravenously.

    Receive methylprednisolone sodium succinate intravenously.

  5. Step 5

    Follow-up and monitoring phase

    Undergo regular monitoring to evaluate the clinical response, focusing on achieving a state where no minimal residual disease (MRD) is detected.

    The primary goal is to assess the MRD negativity rate after three cycles of treatment.

Who can join the trial?

8 criteria

  • Age between 18 and 65 years.
  • Diagnosis of **Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia** (Ph-negative ALL), as determined by a specific test called the BCR/ABL1-like predictor.
  • **WHO score** of 2 or less. This is a measure of general health and ability to perform daily activities.
  • **Adequate liver function**, meaning the liver is working well. This is checked by measuring certain substances in the blood, like bilirubin, ALT, and AST, which should be within specific limits.
  • **Adequate pancreatic function**, meaning the pancreas is working well. This is checked by measuring substances called lipase and amylase in the blood, which should be within specific limits.
  • No history of **dyslipidemia** (abnormal cholesterol levels), **thrombotic events** (blood clots), or **cardiac disease** (heart problems).
  • For women who can have children, a negative pregnancy test is required. Both men and women who can have children must agree to use effective birth control during the study and for 12 months after treatment ends.
  • Must provide **signed informed consent**, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

9 criteria

  • Patients with a type of leukemia called Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia cannot participate. This is a specific genetic change in the leukemia cells.
  • Patients who have not been diagnosed with Adult Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia are excluded. This means the leukemia does not have a specific genetic change.
  • Patients who do not have a BCR/ABL1-like profile are excluded. This is a specific pattern in the leukemia cells that the study is looking for.
  • Patients who are not adults are excluded. The study is only for adult patients.
  • Patients who are unable to undergo treatment with Ponatinib in combination with chemotherapy are excluded. Ponatinib is a medication used to treat certain types of leukemia.
  • Patients who are not able to follow the study procedures or attend the required visits are excluded.
  • Patients who have other medical conditions that might interfere with the study treatment or outcomes are excluded.
  • Patients who are pregnant or breastfeeding are excluded, as the study treatment may affect the baby.
  • Patients who are participating in another clinical trial at the same time are excluded.
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Investigated drugs

  • Ponatinib

    is a medication used in this trial to treat patients with a specific type of leukemia called BCR/ABL1-like acute lymphoblastic leukemia. It works by blocking certain proteins that help cancer cells grow, which may help stop the spread of the cancer.

  • Chemotherapy

    refers to a group of cancer-fighting drugs used in combination with Ponatinib in this trial. These drugs work by killing cancer cells or stopping them from dividing, which can help reduce the number of cancer cells in the body.

What is already known about the treatment

Ponatinib – Ponatinib is administered orally in tablet form and is currently being studied in combination with chemotherapy for its effectiveness in treating adult patients with Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia. It is a targeted cancer therapy that works by inhibiting specific proteins involved in the growth of cancer cells, particularly the BCR-ABL1 tyrosine kinase. This medication is classified as a tyrosine kinase inhibitor and is being evaluated for its ability to achieve minimal residual disease negativity in patients with a BCR/ABL1-like profile.

Investigated diseases

Adult Philadelphia Chromosome-Negative 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 called lymphoblasts. Unlike other forms of acute lymphoblastic leukemia, this type does not have the Philadelphia chromosome, a specific genetic abnormality. The disease progresses rapidly, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression requires prompt medical attention to manage the symptoms and control the spread of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510240-20-00Protocol codeGIMEMA ALL2922Estimated enrolment32 patientsSponsorFondazione Gimema Franco Mandelli Onlus

sourced from the EU Clinical Trials Register and site verification

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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.

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