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Study Comparing Ponatinib and Imatinib with Chemotherapy for Patients 55+ 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 known as Acute Lymphoblastic Leukemia (ALL), specifically in patients who have a genetic feature called the Philadelphia chromosome or BCR-ABL positive. The study is designed for patients aged 55 and older. The purpose of the study is to compare the effects of two different treatments when combined with standard chemotherapy. One treatment involves the drug Ponatinib, also known by its code name AP-24534, and the other involves the drug Imatinib.

Participants in the study will be randomly assigned to one of two groups. One group will receive Ponatinib along with chemotherapy, while the other group will receive Imatinib with chemotherapy. Both medications are taken orally in the form of film-coated tablets. The study will monitor the participants over a period to observe the safety and effectiveness of these treatments. The goal is to see how well each treatment works in reducing the cancer cells in the body and to compare the side effects experienced by participants in each group.

Throughout the study, participants will undergo regular check-ups and tests to track their response to the treatment. The study aims to provide valuable information on which combination of drugs is more effective in treating this specific type of blood cancer. The results could help improve treatment options for patients with Philadelphia chromosome positive Acute Lymphoblastic Leukemia in the future.

The research process

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

Step 1
Initial treatment phase
The trial begins with the administration of ponatinib or imatinib in combination with standard chemotherapy. The choice between these medications is determined by random assignment.
Ponatinib is provided as Iclusig 15 mg film-coated tablets and is taken orally. Imatinib is provided as Imatinib TAD 400 mg film-coated tablets and is also taken orally.
The chemotherapy regimen is administered according to standard protocols for treating Philadelphia chromosome positive acute lymphoblastic leukemia.
Step 2
Consolidation phase
Following the initial treatment phase, the consolidation phase involves continued administration of the assigned medication (ponatinib or imatinib) along with chemotherapy.
The goal during this phase is to achieve a molecular response, which is assessed by measuring the BCR-ABL1 transcript levels in the blood.
Step 3
Maintenance phase
After successful completion of the consolidation phase, the maintenance phase begins. This phase involves ongoing treatment with the assigned medication to maintain remission.
Regular monitoring is conducted to ensure the absence of detectable BCR-ABL1 transcripts and to manage any potential side effects.
Step 4
Monitoring and follow-up
Throughout the trial, regular follow-up appointments are scheduled to monitor the patient's health status and response to treatment.
These appointments include blood tests and other assessments to evaluate the effectiveness of the treatment and to detect any adverse effects.

Who can join the trial?

10 criteria

Male or female patients older than 55 years.
Women who cannot have children, either because they have had surgery to remove reproductive organs, have been through menopause for at least 12 months, or have been sterilized.
Patients with a specific type of blood cancer called **Philadelphia chromosome- or BCR-ABL positive acute lymphoblastic leukemia**.
Patients who have not been treated before, except with certain medications like corticosteroids, a single dose of vincristine, up to three doses of cyclophosphamide (not more than a total of 1g/m²), or treatment to manage cancer in the brain and spinal cord.
No uncontrolled cancer involvement in the **central nervous system (CNS)**, which includes the brain and spinal cord.
A **WHO performance status** of less than 2, which means the patient is able to carry out all self-care but unable to carry out any work activities.
Normal levels of potassium and magnesium in the blood, or levels corrected to normal with supplements before starting the study medication.
Signed written consent to participate in the study.
A molecular test for **BCR-ABL1** has been done.
Sexually active male patients with partners who can have children must agree to use effective birth control methods during the study and for at least 6 months after. Effective methods include complete abstinence, birth control pills, hormone devices, hormone rings, patches, implants, injections, or surgical sterilization, combined with another method like condoms or a cervical cap with spermicide.

Who cannot join the trial?

3 criteria

Patients who do not have blood cancer cannot participate. Blood cancer is a type of cancer that affects the blood, bone marrow, or lymph nodes.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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

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Besancon University Hospital Center
Besançon, France
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Centre Hospitalier De Versailles
Le Chesnay-Rocquencourt, France
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Centre Hospitalier Sud Francilien
Corbeil Essonnes, France

Trial locations

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Investigated drugs

Ponatinib
is a medication used in this trial to treat patients with a specific type of leukemia known as Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). It works by blocking certain proteins that help cancer cells grow, which may help stop the spread of the cancer.
Imatinib
is another medication used in the trial for treating the same type of leukemia. It also targets proteins involved in cancer cell growth, aiming to slow down or stop the progression of the disease.

What is already known about the treatment

Ponatinib
This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating blood cancer, specifically Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Ponatinib works by inhibiting the activity of certain proteins that promote cancer cell growth, particularly the BCR-ABL protein. It is classified as a tyrosine kinase inhibitor, which helps to block the signals that cause cancer cells to multiply.
Imatinib
This medication is also taken orally as a tablet. It is well-established in medical literature and is used to treat various types of blood cancer, including Ph+ ALL. Imatinib functions by targeting and blocking the BCR-ABL protein, which is responsible for the uncontrolled growth of cancer cells. It belongs to the pharmacological class of tyrosine kinase inhibitors, which are designed to interfere with specific enzymes involved in cancer cell proliferation.

Investigated diseases

Blood Cancer – Blood cancer is a type of cancer that affects the blood, bone marrow, or lymphatic system. It often begins in the bone marrow, where blood is produced, and leads to the production of abnormal blood cells. These abnormal cells can interfere with the normal functioning of blood cells, such as fighting infections or preventing bleeding. As the disease progresses, it can spread to other parts of the body, affecting organs and tissues. Symptoms may include fatigue, frequent infections, and easy bruising or bleeding. The progression of blood cancer varies depending on the specific type and individual factors.