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Study for Adults with Very High-Risk T-Cell Acute Lymphoblastic Leukemia Using Daratumumab and a Drug Combination

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 treating adults with a specific type of blood cancer called Very High-Risk T-cell Acute Lymphoblastic Leukemia (T-ALL). The study will use a medication called Daratumumab, which will be added to the standard treatment program for this disease. The purpose of the study is to see if adding Daratumumab can improve the treatment outcomes for patients with this high-risk form of leukemia.

Participants in the study will receive Daratumumab along with the usual chemotherapy treatments. The study will monitor how well the cancer responds to this combination, particularly looking at whether the cancer cells are reduced to very low levels after the first cycle of treatment. This is known as achieving MRD-negativity, which stands for minimal residual disease negativity, indicating that very few cancer cells remain in the body.

The study will take place over several years, with regular assessments to track the progress of the treatment. Participants will receive various medications, including Cyclophosphamide, Prednisone, Dexamethasone Sodium Phosphate, Ondansetron, Methotrexate, Lenograstim, Diphenhydramine, Rasburicase, Human Fibrinogen, Pegaspargase, Allopurinol, Idarubicin Hydrochloride, Hydrocortisone, Co-trimoxazole, Vincristine Sulfate, Micafungin, Aciclovir, Chlorphenamine, Foscarnet, Levofloxacin, Folinic Acid, Ciprofloxacin, Amphotericin B, Levocarnitine, Paracetamol, Montelukast, Aprepitant, Furosemide, Mercaptopurine, Ganciclovir, Cytarabine, Granisetron, Methylprednisolone Sodium Succinate, Salbutamol, and Filgrastim, as part of their treatment plan. Some participants may receive a placebo instead of Daratumumab to compare the effects. The study aims to provide valuable insights into improving treatment for this challenging form of leukemia.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. Consent will be obtained to ensure understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests.

  3. Step 3

    Induction phase

    The induction phase involves the administration of chemotherapy combined with daratumumab. The goal is to reduce the number of leukemia cells in the body.

    Medications such as cyclophosphamide, prednisone, dexamethasone sodium phosphate, and vincristine sulfate may be used. These are given through intravenous (IV) infusions or orally, depending on the specific drug.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring will occur to evaluate the response to treatment. This includes blood tests and possibly bone marrow examinations to assess the presence of leukemia cells.

  5. Step 5

    Consolidation phase

    Following successful induction, the consolidation phase aims to eliminate any remaining leukemia cells. This phase may involve additional chemotherapy and daratumumab administration.

  6. Step 6

    Maintenance phase

    The maintenance phase is designed to prevent the return of leukemia. It involves lower doses of chemotherapy over a longer period, possibly including medications like mercaptopurine and methotrexate.

  7. Step 7

    Follow-up

    After completing the treatment phases, regular follow-up visits will be scheduled to monitor health status and detect any signs of leukemia returning.

Who can join the trial?

10 criteria

  • Age between 18 and 65 years.
  • Must sign a written informed consent, which is a document that explains the study and confirms your agreement to participate.
  • Must have a diagnosis of T-Lineage Acute Lymphoblastic Leukemia (T-ALL), which is a type of blood cancer. This can be a new diagnosis or one that developed after treatment for another cancer.
  • Must provide fresh samples of bone marrow or blood for testing. Bone marrow is the soft tissue inside bones where blood cells are made.
  • At diagnosis, the percentage of cancer cells in the bone marrow must be 20% or higher.
  • The cancer cells must show some level of CD38 positivity. CD38 is a protein found on the surface of certain cells.
  • Must have specific subtypes of T-ALL, which are determined by certain characteristics of the cancer cells, such as white blood cell count or genetic features.
  • Must have a complete analysis of the disease, including tests that look at the cells, their chemical properties, and genetic information.
  • Must have an ECOG performance status of 0 to 2. This is a scale that measures how well you can perform daily activities. A score of 3 is allowed if it is clearly due to the disease and can improve with treatment.
  • Females who can become pregnant must have a negative pregnancy test. Both male and female participants who can have children must agree to use effective birth control during the study and for 12 months after treatment ends.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of leukemia other than Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL) cannot participate. This is a specific type of blood cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate. This includes conditions that could make it unsafe for them to take part.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
  • Patients who have allergies or reactions to the study medication or similar medications cannot participate.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study requirements, cannot participate.
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Investigated drugs

Daratumumab is a medication used in this clinical trial to treat adults with very high-risk T-Lineage Acute Lymphoblastic Leukemia (T-ALL). It is being added to the standard treatment to see if it can help increase the rate of patients achieving MRD-negativity, which means having no detectable cancer cells after the first cycle of treatment. Daratumumab works by targeting specific proteins on the surface of cancer cells, helping the immune system to identify and destroy them.

What is already known about the treatment

Daratumumab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating very high-risk T-Lineage Acute Lymphoblastic Leukemia (ALL). It is primarily used in combination with standard chemotherapy to improve treatment outcomes. Daratumumab works by targeting a specific protein on the surface of cancer cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells known as lymphoblasts. It specifically involves T-lineage cells, which are a subset of lymphocytes. The disease progresses rapidly, leading to a high number of abnormal cells that crowd out normal blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The condition is considered very high-risk due to its aggressive nature and potential for rapid progression. It requires intensive treatment to manage the proliferation of cancerous cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511627-34-00Protocol codeALL3024Estimated enrolment31 patientsSponsorFondazione Gimema Franco Mandelli Onlus

sourced from the EU Clinical Trials Register and site verification

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