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Study on Ponatinib and Imatinib for Adults 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 Acute Lymphoblastic Leukemia (ALL), specifically a form that is positive for the Philadelphia Chromosome. The study aims to evaluate the effectiveness of different treatments for this condition. The treatments being tested include a medication called Ponatinib, another medication named Imatinib, and a drug known as Blinatumomab. These medications are used in combination with low-intensity chemotherapy, which is a treatment that uses drugs to kill cancer cells or stop them from growing.

The purpose of the study is to compare the effectiveness of these treatments in patients with this specific type of leukemia. Participants will receive either Ponatinib or Imatinib along with chemotherapy. In some cases, Blinatumomab will be used for patients who respond optimally or suboptimally to the initial treatment. The study will also look at the end of therapy with an indication for stem cell transplantation (SCT) versus the use of these medications and chemotherapy.

The study will take place over several weeks, with different phases of treatment. Participants will receive the medications either orally or through an intravenous infusion, which means the medicine is given directly into a vein. The trial will monitor the overall survival of patients and the rate of complete remission, which means the disappearance of all signs of cancer in response to treatment. The goal is to determine which combination of treatments is most effective 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.

Step 1
Initial treatment phase
Begin with a standard prephase treatment that includes dexamethasone and cyclophosphamide. This phase may also involve intrathecal therapy, hydroxyurea, a single dose of vincristine, and other cytostatic drugs.
Start the standard induction for Philadelphia chromosome-positive acute lymphoblastic leukemia. This includes one dose of vincristine, one dose of rituximab, two doses of dexamethasone, and up to five days of imatinib.
Step 2
Randomized treatment phase
Participate in a randomized trial to assess the effectiveness of ponatinib versus imatinib in combination with low-intensity chemotherapy.
Receive either ponatinib or imatinib orally, depending on the group assignment.
Step 3
Chemotherapy and blinatumomab phase
Undergo chemotherapy alternating with blinatumomab for those who respond optimally to the initial treatment.
Blinatumomab is administered intravenously as a solution for infusion.
Step 4
Evaluation phase
Evaluate the response to treatment. Optimal responders may continue with the current treatment plan, while suboptimal responders may receive additional blinatumomab therapy.
The goal is to achieve molecular complete remission by week 11 after consolidation with chemotherapy.
Step 5
End of therapy phase
Conclude the therapy with an assessment of the need for further treatment, such as stem cell transplantation (SCT) or continued use of tyrosine kinase inhibitors (TKI) like imatinib or ponatinib.

Who can join the trial?

15 criteria

Must be a male or female patient aged between 18 and 65 years.
Must have a specific type of leukemia called **Philadelphia chromosome or BCR::ABL1 positive ALL**.
Should not have received any previous treatment except for certain medications like corticosteroids for up to 7 days.
Must have undergone a standard pre-treatment phase with specific drugs like dexamethasone and cyclophosphamide, including some other treatments.
Must have started standard induction treatment for Ph-positive ALL, which includes specific doses of drugs like vincristine, Rituximab, dexamethasone, and Imatinib.
Must have an **ECOG performance status** of 2 or less, which is a measure of how well a patient can perform daily activities.
Must have signed a written informed consent form.
Must have undergone a **molecular evaluation** for BCR::ABL1.
Women of childbearing potential must have a negative pregnancy test.
Women of childbearing potential must agree to use two highly effective methods of contraception during the study and for three months after the last dose.
Men with female partners of childbearing potential must agree to use two highly effective forms of contraception during the study and for at least three months after the last dose.
Must have normal levels of potassium and magnesium in the blood, or these levels should be corrected with supplements before starting the study medication.
Must have a **serum lipase** level that is 1.5 times the upper limit of normal or less. If higher, it should not be clinically significant or linked to risk factors for acute pancreatitis.
Must have a normal **QTcF interval**, which is a measure of heart rhythm, of 450 ms or less for males and 470 ms or less for females.
Must participate in the registry of the German Multicenter Study Group for Adult ALL (GMALL).

Who cannot join the trial?

10 criteria

Patients with other types of leukemia or blood disorders cannot participate.
Patients who have had previous treatments for leukemia that are not part of the study are excluded.
Patients with severe heart problems or other serious health conditions are not eligible.
Pregnant or breastfeeding women cannot take part in the study.
Patients who are unable to follow the study procedures or attend regular check-ups are excluded.
Patients with a history of other cancers, unless they have been in remission for a certain period, are not eligible.
Patients who are currently participating in another clinical trial are excluded.
Patients with known allergies to the study medications cannot participate.
Patients with active infections that require treatment are not eligible.
Patients with a history of drug or alcohol abuse that could interfere with the study are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Responsive
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany

Trial locations

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Investigated drugs

Ponatinib
is a medication used in this trial to treat adults with a specific type of leukemia known as Philadelphia-Chromosome positive acute lymphoblastic leukemia (Ph+ ALL). It is a type of drug called a tyrosine kinase inhibitor (TKI), which works by blocking certain proteins that help cancer cells grow.
Imatinib
is another tyrosine kinase inhibitor used in the trial. Like ponatinib, it targets proteins that promote the growth of cancer cells. It is used in combination with low-intensity chemotherapy to treat the leukemia.
Blinatumomab
is a type of therapy used in the trial for patients who respond optimally or suboptimally to initial treatments. It is a type of immunotherapy that helps the immune system recognize and attack cancer cells. It is used in combination with other treatments to improve outcomes for patients with Ph+ ALL.

What is already known about the treatment

Ponatinib
Ponatinib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating Philadelphia-Chromosome positive acute lymphoblastic leukemia (Ph+ ALL). It is a tyrosine kinase inhibitor that works by blocking the activity of specific proteins involved in the growth of cancer cells. This medication is classified as a targeted cancer therapy and is being compared to other treatments to assess its efficacy in improving overall survival rates in patients.
Imatinib
Imatinib is taken orally as a tablet and is well-established in medical literature as a treatment for various types of cancer, including Ph+ acute lymphoblastic leukemia. It functions by inhibiting the BCR-ABL protein, which is responsible for the uncontrolled growth of cancer cells. Imatinib is classified as a tyrosine kinase inhibitor and is being evaluated in combination with low-intensity chemotherapy to determine its effectiveness compared to other treatment regimens.
Blinatumomab
Blinatumomab is administered through intravenous infusion and is used in the treatment of Ph+ acute lymphoblastic leukemia. It is a type of immunotherapy that works by engaging the body's immune system to target and destroy cancer cells. Classified as a bispecific T-cell engager, Blinatumomab is being studied for its potential to improve outcomes in patients who respond suboptimally to other treatments.

Investigated diseases

Acute Lymphoblastic Leukemia (ALL), de novo, Ph/BCR::ABL1 positive (Ph+) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. The "de novo" term indicates that the disease arises spontaneously, not from a pre-existing condition. The presence of the Philadelphia chromosome (Ph+) or BCR::ABL1 fusion gene is a specific genetic abnormality associated with this leukemia, which can influence the behavior of the disease. The disease progresses rapidly, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of normal blood cells. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression of ALL requires careful monitoring and management to address the rapid changes in the patient's condition.