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Study on the Safety and Effectiveness of Isatuximab and Drug Combination for Adults with Relapsed or Refractory CD38 Positive T-cell 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 T-cell acute lymphoblastic leukemia (T-ALL), specifically in cases where the disease has returned or is resistant to treatment. The study is investigating the use of a medication called Isatuximab, which is a humanized monoclonal antibody targeting a protein known as CD38 found on the surface of certain cancer cells. The purpose of the study is to evaluate the safety and effectiveness of Isatuximab in treating this condition.

Participants in the study will receive Isatuximab as part of a combination chemotherapy regimen or as a single treatment, depending on their specific condition. The study will monitor how well the treatment works in reducing cancer cells and achieving remission, which means the absence of detectable cancer. The treatment will be administered through an intravenous infusion, which involves delivering the medication directly into the bloodstream through a vein.

The study will take place over a period of time, with regular visits to monitor the participants' health and response to the treatment. The goal is to determine if Isatuximab can help patients achieve remission and improve their overall survival. The study will also track any side effects experienced by participants to ensure the treatment is safe and tolerable. This research aims to provide new insights into the treatment of T-ALL and potentially offer a new therapeutic option for patients with this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Upon joining the study, the patient will begin treatment with Isatuximab, administered as a solution for infusion. This medication is given intravenously, meaning it is delivered directly into the bloodstream through a vein.

    The initial phase involves receiving Isatuximab as part of a combination chemotherapy regimen. The specific schedule and dosage will be determined by the healthcare provider based on the patient's condition and response to treatment.

  2. Step 2

    Combination chemotherapy

    The patient will receive a combination of medications, including Cytarabine, Cyclophosphamide, Daunorubicin, Bortezomib, Methotrexate, Vincristine, Dexamethasone, Pegaspargase, and Mercaptopurine. These medications are administered through various routes such as intravenous, intrathecal (into the spinal canal), subcutaneous (under the skin), and oral (by mouth).

    The treatment regimen is designed to target cancer cells and may involve different cycles, with each cycle consisting of specific medications given over a set period. The healthcare team will provide detailed instructions on the timing and sequence of each medication.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, the patient's response to treatment will be closely monitored. This includes regular blood tests, imaging studies, and other assessments to evaluate the effectiveness of the therapy and to detect any side effects.

    The primary goal is to achieve a complete hematologic response, which means the absence of detectable cancer cells in the blood and bone marrow. The healthcare team will also assess the patient's overall health and quality of life during the study.

  4. Step 4

    Adjustments and follow-up

    Based on the patient's response to treatment, adjustments to the medication regimen may be made. This could involve changes in dosage, frequency, or the addition of other supportive therapies to manage side effects.

    Regular follow-up visits will be scheduled to ensure the patient's safety and to address any concerns that may arise during the trial. The healthcare team will provide guidance on managing symptoms and maintaining well-being throughout the study.

  5. Step 5

    Completion of trial

    The trial is expected to continue until the estimated end date in 2028. Upon completion, the patient's overall response to the treatment will be evaluated, and further recommendations for care will be provided.

    The results of the trial will contribute to understanding the safety and efficacy of Isatuximab in treating relapsed or refractory T-cell acute lymphoblastic leukemia.

Who can join the trial?

28 criteria

  • Patients must have **CD38 positive T-cell acute lymphoblastic leukemia (T-ALL)**.
  • Must fit the definitions for either **cohort 1** or **cohort 2**.
  • Must have **adequate kidney function**, which means:
    • Serum creatinine (a waste product in the blood) should be less than or equal to 2 times the upper limit of normal (ULN).
    • Creatinine clearance (a measure of kidney function) should be 40 mL/min or higher.
    • Women who can have children must have a **negative pregnancy test**.
    • Women who can have children must agree to either not have heterosexual intercourse or use two reliable birth control methods at the same time.
    • Men who are sexually active with women who can have children must agree to use a **barrier method of contraception** (like a condom).
    • Must participate in the **registry of the German Multicenter Study Group for Adult ALL (GMALL)**.
    • For **cohort 1**:
      • Must be in **relapse** or have **primary refractory disease**, which means:
        • 5% or more cancer cells (blasts) in the bone marrow after at least three chemotherapy cycles.
        • Early relapse within 12 months from first complete remission (CR) or late relapse after 12 months.
        • Primary refractory disease without any complete remission.
        • Any relapse after stem cell transplantation.
        • Any refractory relapse, meaning no response to at least one additional therapy.
        • Any second or later relapse.
        • Availability of patient material with blast cells for central **minimal residual disease (MRD)** assessment.
        • For **cohort 2**:
          • Must be in **complete hematological remission**, meaning less than 5% blasts in bone marrow and no disease outside the bone marrow after at least three chemotherapy cycles.
          • Must have detectable **minimal residual disease (MRD)** at a certain level, either as molecular failure or molecular relapse.
          • MRD testing must be done at a central lab with specific sensitivity.
          • MRD detection for study inclusion must be after at least 2 weeks from the last systemic chemotherapy.
          • Must have an **ECOG status** (a measure of daily living abilities) of:
            • 0-2 for cohort 1.
            • 0-1 for cohort 2.
            • Must be **18 years or older**.
            • Must provide **signed and dated informed consent**, indicating understanding of the study.
            • Must be willing and able to follow the study schedule, treatment plan, and tests.
            • Must have **recovered from the last chemotherapy**, defined as:
              • For cohort 1: Platelets 10,000/µL or more (transfusions allowed), Hemoglobin 7.5 g/dL or more (transfusions allowed).
              • For cohort 2: Neutrophils 1,000/µL or more, Platelets 50,000/µL or more, Hemoglobin 9 g/dL or more.
              • Must have **adequate liver function**, which means:
                • Bilirubin (a substance made by the liver) should be less than or equal to 1.5 times the upper limit of normal, unless due to specific conditions.
                • AST and ALT (liver enzymes) should be less than or equal to 2.5 times the upper limit of normal, unless due to specific conditions.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of leukemia that is not **CD38 positive T-cell acute lymphoblastic leukemia**.
  • Patients who are not experiencing a **relapsed** (return of the disease) or **refractory** (disease not responding to treatment) condition.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific health criteria set by the study.
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Investigated drugs

Isatuximab is a medication being studied for its ability to treat certain types of leukemia. It is used in this trial to target and attack cancer cells that have a specific marker called CD38 on their surface. In one part of the study, Isatuximab is combined with other chemotherapy drugs to see if it can help patients whose leukemia has returned or not responded to previous treatments. In another part, Isatuximab is used alone to see if it can help reduce the number of cancer cells to a very low level in patients who still have some cancer cells remaining after initial treatment.

What is already known about the treatment

Isatuximab – Isatuximab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness and safety in treating certain types of leukemia, specifically CD38 positive T-cell acute lymphoblastic leukemia that has relapsed or is resistant to treatment. The main therapeutic use of Isatuximab is to target and bind to the CD38 protein on the surface of cancer cells, which helps the immune system to identify and destroy these cells. It belongs to a class of medications known as monoclonal antibodies, which are designed to specifically target certain proteins on cancer cells.

Investigated diseases

T-cell Acute Lymphoblastic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature T-cells, a type of white blood cell. It progresses rapidly, leading to an accumulation of these cells in the bone marrow, which can interfere with the production of normal blood cells. Patients may experience symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. The disease can also spread to other parts of the body, including the lymph nodes, liver, and spleen. In some cases, it may involve the central nervous system, leading to neurological symptoms. The condition is considered rare and requires specialized medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507899-47-00Protocol codeGMALL-IsatuximabEstimated enrolment28 patientsSponsorGoethe University Frankfurt

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