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Study of olverembatinib with chemotherapy versus standard therapy in adults 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 studying a treatment for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) in newly diagnosed patients. The study tests a new medication called olverembatinib used together with chemotherapy drugs. The chemotherapy medications include vincristine, cytarabine, methotrexate, dexamethasone, and prednisolone.

The study compares two treatment approaches: one group receives olverembatinib with chemotherapy, while the other group receives different medications called tyrosine kinase inhibitors (which may include dasatinib, ponatinib, or imatinib) combined with the same chemotherapy drugs. The main purpose is to find out how well olverembatinib works compared to current treatments in eliminating cancer cells from the body.

During the study, patients will receive their assigned medications for several months. Doctors will regularly check the amount of cancer cells in the blood and bone marrow to see how well the treatment is working. They will also monitor patients for any side effects from the medications and track their overall health and survival over time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase - Induction therapy

    You will receive a combination of chemotherapy and a study medication called olverembatinib

    The medications will be given through different methods:

    - Vincristine sulfate through IV infusion

    - Prednisolone as oral tablets

    - Methotrexate through IV infusion and spinal injection

    - Dexamethasone as oral tablets and through IV

    - Cytarabine through IV infusion and spinal injection

  2. Step 2

    Response evaluation

    Your response to the treatment will be checked through blood tests and bone marrow examination

    The main goal is to achieve a complete response, which means:

    - No cancer cells in blood

    - Less than 5% cancer cells in bone marrow

    - Normal blood cell counts

    - No signs of cancer outside the bone marrow

  3. Step 3

    Continuation therapy

    If you respond well to the initial treatment, you will continue receiving therapy

    The treatment will include regular doses of:

    - Olverembatinib taken by mouth

    - Additional chemotherapy medications as prescribed by your doctor

    Regular blood tests and examinations will monitor your progress

  4. Step 4

    Follow-up period

    After completing the treatment phase, you will have regular follow-up visits

    These visits will include:

    - Blood tests

    - Physical examinations

    - Monitoring for any signs of disease return

    The total study duration is expected to continue until February 2027

Who can join the trial?

8 criteria

  • Must be 18 years or older

  • Must be newly diagnosed with Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) and not have received previous systemic treatment, except for:

    • Hydroxycarbamide treatment
    • One-time vincristine treatment
    • Steroid therapy lasting no more than 28 days
  • Must have a life expectancy of at least 3 months
  • Must have an ECOG performance status of 2 or less (a measure of patient's ability to perform daily activities)

  • Must have adequate organ function, including:

    • Liver function within specified limits
    • Kidney function within specified limits
    • Normal blood clotting measures
    • Heart function showing ejection fraction above 50%
    • Normal cardiac markers
    • Normal heart rhythm measurements

  • Must agree to use effective birth control methods during treatment and for 4 months after the last dose. This applies to:

    • Both men and women who can have children
    • Male participants must not donate sperm
  • Women who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
  • Must be able to understand and sign an informed consent form and complete all study procedures and follow-up examinations

Who cannot join the trial?

13 criteria

  • Prior treatment with any therapy for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL), except for emergency treatment with steroids for up to 7 days
  • History of another type of cancer within the past 3 years, except for successfully treated skin cancer or early-stage cancer
  • Serious heart conditions including:
    • Uncontrolled high blood pressure
    • Heart attack in the past 6 months
    • Severe heart rhythm problems
    • Active, uncontrolled infections requiring treatment
    • Known active hepatitis B or C infection
    • HIV positive patients
    • Severe kidney or liver problems
    • Pregnant or breastfeeding women
    • Unable to swallow oral medications
    • Any condition that could interfere with the patient's ability to follow study requirements
    • Participation in another clinical trial within 30 days before starting this study
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Investigated drugs

  • Olverembatinib

    is a targeted therapy medication known as a tyrosine kinase inhibitor (TKI). It works by blocking specific proteins that contribute to cancer cell growth in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. This medication is given in combination with chemotherapy drugs to treat newly diagnosed patients.

  • Tyrosine Kinase Inhibitors (TKIs)

    are a class of medications that work by blocking specific proteins involved in cancer cell growth. In this trial, various TKIs are used as comparison treatments, combined with chemotherapy, according to the investigator's choice.

  • Chemotherapy

    refers to traditional cancer-fighting medications that work by killing rapidly dividing cells in the body. These medications are used in combination with either olverembatinib or other TKIs to treat leukemia.

What is already known about the treatment

Olverembatinib - A targeted therapy medication administered orally that belongs to the class of tyrosine kinase inhibitors (TKIs) used in the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This drug works by blocking specific proteins that promote cancer cell growth, specifically targeting the BCR-ABL protein that is characteristic of Ph+ ALL. Currently undergoing Phase 3 clinical trials, olverembatinib is being studied in combination with chemotherapy as a potential first-line treatment option for newly diagnosed Ph+ ALL patients, with particular focus on achieving minimal residual disease-negative complete response.

Investigated diseases

Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) - A type of blood and bone marrow cancer where the body produces abnormal white blood cells containing a specific genetic mutation called the Philadelphia chromosome. The disease develops rapidly, with abnormal lymphoid cells (lymphoblasts) multiplying quickly and replacing normal blood cells in the bone marrow. These malignant cells eventually spread into the bloodstream and can infiltrate other organs. The condition affects the body's ability to produce normal blood cells, leading to decreased production of red blood cells, platelets, and healthy white blood cells. The presence of the Philadelphia chromosome makes this form of leukemia distinct from other types of acute lymphoblastic leukemia.
Trial detailsLast updated 15 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511496-14-00Protocol codeHQP1351AG301Estimated enrolment297 patientsSponsorAscentage Pharma Group Inc.

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