Recruiting

Study on Blinatumomab, Ponatinib, and Isatuximab for Adults Aged 18-65 with Newly Diagnosed Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma

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 treatments for a type of blood cancer called Acute Lymphoblastic Leukemia (ALL) and a related condition known as T-cell Lymphoblastic Lymphoma (T-LL). The study involves several medications, including blinatumomab, isatuximab, and ponatinib. Blinatumomab, also known by its code names MT-103 and MEDI-538, is a type of protein that helps the immune system target cancer cells. Isatuximab, sometimes referred to as SAR650984, is another protein that targets specific markers on cancer cells. Ponatinib, also known as AP-24534, is a chemical compound that blocks certain proteins involved in cancer cell growth.

The purpose of this study is to explore how these new treatments can improve outcomes for adults with newly diagnosed ALL or T-LL. Participants will be divided into different groups to receive these treatments, sometimes in combination with a procedure called Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), which involves replacing diseased bone marrow with healthy cells from a donor. The study will follow participants over a period to observe the effects of these treatments on their health and cancer progression.

Throughout the study, participants will receive either the study medications or a placebo, and their health will be monitored regularly. The study aims to determine if these new treatments can help improve survival rates and reduce the risk of cancer returning. Participants will be closely observed for any side effects and overall quality of life during the treatment period. The study is expected to continue for several years to gather comprehensive data on the effectiveness and safety of these treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a series of tests to classify your condition as either Ph-positive or Ph-negative B-ALL, or T-ALL.
Step 2
Treatment plan discussion
A healthcare professional will discuss the treatment plan with you, explaining the medications involved and the schedule for their administration. You will be informed about the potential benefits and risks associated with the trial.
Step 3
Medication administration
You will receive the medication blinatumomab as a solution for infusion. The dosage and frequency will be determined by the healthcare team based on your specific condition.
If you are in the Ph-positive B-ALL cohort, you will also receive ponatinib in the form of 15 mg film-coated tablets, taken orally. The frequency and duration will be specified by your healthcare provider.
For those in the T-ALL cohort, isatuximab will be administered as a solution for infusion. The healthcare team will provide details on the dosage and schedule.
Step 4
Regular monitoring
Throughout the trial, you will have regular check-ups to monitor your response to the treatment. This includes blood tests and other necessary evaluations to assess your health and the effectiveness of the medication.
Step 5
Follow-up visits
You will be required to attend follow-up visits as scheduled by the healthcare team. These visits are crucial for tracking your progress and making any necessary adjustments to your treatment plan.
Step 6
Completion of trial
At the end of the trial, a final assessment will be conducted to evaluate the overall outcome of the treatment. You will receive information on the next steps and any further treatment options if needed.

Who can join the trial?

9 criteria

Patients must be between 18 and 65 years old.
Must have a newly diagnosed condition called ALL or T-LL. These are specific types of blood cancer.
Must have certain tests done to classify the type of cancer. These tests include immunophenotypic, cytogenetic, FISH, and molecular evaluation. These tests help doctors understand the specific characteristics of the cancer.
Should not have received any previous treatment for the cancer, except for corticosteroids and/or intrathecal therapy. Corticosteroids are a type of medication, and intrathecal therapy is a way to deliver drugs directly into the spinal fluid.
Must be eligible for a procedure called allo-HSCT if they have certain types of ALL. This is a type of stem cell transplant.
Must have an ECOG performance status of 2 or less. This is a scale used to assess how well a patient can perform daily activities. A score of 2 or less means the patient is able to carry out most activities.
Must be willing and able to understand the study requirements and follow the treatment schedule, attend scheduled visits, and complete necessary exams and reports.
Must sign a written consent form to participate in the study.
If a woman is of child-bearing potential or a man has a partner who is, they must agree to use effective contraception during the study and for at least 6 months after. Effective contraception means methods that have a failure rate of less than 1% per year when used correctly.

Who cannot join the trial?

8 criteria

Patients who are not between the ages of 18 and 65.
Patients who have already received treatment for their condition.
Patients with a type of leukemia called Ph-positive B-ALL who are not eligible for the specific treatments being tested.
Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently.
Patients with a history of allergic reactions to the study medications.

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Verified sites

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

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Grand Hopital De Charleroi
Charleroi, Belgium

Trial locations

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Investigated drugs

Blinatumomab
is a type of immunotherapy used in the treatment of certain types of blood cancer, specifically acute lymphoblastic leukemia (ALL). It works by helping the body's immune system recognize and attack cancer cells. In this trial, blinatumomab is being tested to see if it can improve outcomes for patients by being used early in the treatment process.
Isatuximab
is another immunotherapy drug that targets specific proteins on the surface of cancer cells. It is used to help the immune system find and destroy these cells. In this study, isatuximab is being evaluated for its effectiveness in treating patients with T-cell acute lymphoblastic leukemia (T-ALL) when used early in their treatment.
Ponatinib
is a medication that targets specific proteins involved in the growth of cancer cells. It is used to treat certain types of leukemia, including those that are resistant to other treatments. In this clinical trial, ponatinib is being tested to see if it can improve outcomes for patients with a specific type of leukemia when used in combination with other therapies.

What is already known about the treatment

Blinatumomab
Blinatumomab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating adults with certain types of acute lymphoblastic leukemia (ALL), specifically those who are newly diagnosed and have not been treated before. The medication works by helping the immune system target and destroy cancer cells. It belongs to a class of drugs known as bispecific T-cell engagers, which are designed to connect T-cells, a type of immune cell, to cancer cells, facilitating their destruction.
Isatuximab
Isatuximab is given as an intravenous infusion, which involves delivering the medication directly into the bloodstream through a vein. It is being explored in clinical trials for its potential to improve outcomes in adults with T-cell acute lymphoblastic leukemia (T-ALL). The drug functions by targeting a specific protein on the surface of cancer cells, helping the immune system to recognize and attack these cells. Isatuximab is classified as a monoclonal antibody, a type of drug that is engineered to bind to specific proteins on cancer cells.
Ponatinib
Ponatinib is taken orally in the form of a tablet, which means it is swallowed and absorbed through the digestive system. It is being investigated in clinical trials for its role in treating adults with a specific type of acute lymphoblastic leukemia (ALL) that is positive for the Philadelphia chromosome. Ponatinib works by blocking certain proteins that promote the growth of cancer cells, thereby inhibiting their proliferation. It is classified as a tyrosine kinase inhibitor, a type of medication that targets enzymes involved in the signaling pathways of cancer cell growth.

Investigated diseases

Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as lymphoblasts. These cells crowd out normal cells, leading to symptoms such as fatigue, fever, and easy bruising or bleeding. The disease progresses rapidly, requiring prompt medical intervention. As the condition advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression involves a series of phases, starting with the accumulation of lymphoblasts and potentially leading to more severe health complications if untreated.
T-cell Acute Lymphoblastic Leukemia (T-ALL)
T-cell Acute Lymphoblastic Leukemia is a subtype of acute lymphoblastic leukemia that originates from T-lymphocytes. It involves the rapid proliferation of immature T-cells, which can infiltrate various organs and tissues. This disease often presents with symptoms such as enlarged lymph nodes, fever, and a high white blood cell count. The progression is typically swift, with the potential for the disease to spread to the central nervous system and other areas. As the disease advances, it can lead to significant disruptions in normal blood cell production. The rapid growth of T-cells can cause complications if not addressed promptly.