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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Institut Curie – Site Paris Paris France
CHU Grenoble Alpes La Tronche France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospital Region Metz Thionville Metz France
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
CHU Helora La Louviere Belgium
Centre Hospitalier De Valenciennes Valenciennes France
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Aqkaoodv Zblesagtky Dscbb Roeselare Belgium
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Grhasa Hydtgxeutcd Db Ld Rqnpwk Dj Mcxeqiyg Ei Soy Amlbih Mulhouse France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.10.2024
France France
Recruiting
15.10.2024

Trial locations

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.

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.

Trial ID:
2024-511437-35-00
NCT ID:
NCT06860269
Trial Phase:
Therapeutic use (Phase IV)

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