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Study of Monalizumab for Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Haploidentical Transplantation

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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 two blood-related diseases: Acute Myeloid Leukemia and Myelodysplastic Syndrome. These are conditions where the bone marrow does not produce blood cells properly. The treatment being tested is called Monalizumab, which is a type of medication known as a monoclonal antibody. Monalizumab is given as a solution through an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how effective and safe Monalizumab is for patients who have undergone a specific type of stem cell transplant called haploidentical hematopoietic stem cell transplantation. This type of transplant is used when a patient does not have a fully matched donor. After the transplant, patients receive a medication called cyclophosphamide to help prevent complications. The study will look at how well Monalizumab works in this setting and monitor any side effects.

Participants in the study will receive Monalizumab after their stem cell transplant. The study will track their progress over time to see how the treatment affects their health, including the incidence of infections and the behavior of certain immune cells. The study aims to provide valuable information on the potential benefits and risks of using Monalizumab in treating these serious blood disorders.

The research process

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

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring the patient meets the criteria for participation, such as having acute myeloid leukemia or myelodysplastic syndrome and lacking a human leukocyte antigen identical donor.
Step 2
Haploidentical stem cell transplantation
The patient undergoes a haploidentical stem cell transplantation (Haplo-SCT). This involves receiving stem cells from a partially matched donor. The procedure may include a conditioning regimen that can be myeloablative, reduced intensity, or non-myeloablative, followed by a bone marrow or peripheral blood stem cell graft.
Step 3
Post-transplantation medication
After the transplantation, medications are administered to prevent complications. Cyclophosphamide is given at 40 or 50 mg/kg/day on days +3 and +4. Cyclosporine A is administered at 3 mg/kg/day starting from day +5. Mycophenolate mofetil is given at 45 mg/kg/day from day +5 to day +35.
Step 4
Monalizumab infusion
The patient receives an infusion of Monalizumab, a solution for infusion administered intravenously. This medication is an anti-NKG2A monoclonal antibody aimed at improving the outcomes of the transplantation.
Step 5
Monitoring and follow-up
The patient's response to the treatment is closely monitored. This includes evaluating the efficacy and safety of Monalizumab in terms of graft-versus-host disease prevention and overall survival. The study also assesses the reconstitution of natural killer cells and their function against leukemic cells.

Who can join the trial?

7 criteria

Patients must be able to give their agreement to participate in the study and follow all the study procedures.
Patients must be adults, which means they are 18 years old or older. There are no restrictions based on gender or race.
Patients must have a blood-related cancer, specifically either **Acute Myeloid Leukemia** or **Myelodysplastic Syndrome**. This can also include a condition called **Myelodysplastic Syndrome/Myeloproliferative Neoplasm**.
Patients must not have a matching **human leukocyte antigen (HLA)** donor. They should have received a type of transplant called **Haplo-SCT** with specific medications to prevent complications. These medications include **Cyclophosphamide**, **Cyclosporine A**, and **Mycophenolate mofetil**.
Patients must have received a **Haplo-SCT** transplant with different types of preparation, which can be strong, less intense, or not intense, followed by either a **bone marrow** or **peripheral blood stem cell** transplant.
Women who can have children must have a negative pregnancy test within 7 days before starting the study medication.
Women who can have children must agree to use a very effective birth control method from the time they agree to participate until at least 52 weeks after their last dose of the study medication. Men with female partners who can have children must also agree to use a very effective birth control method during the same time period.

Who cannot join the trial?

1 criterion

Patients with **acute myeloid leukemia** or **myelodysplastic syndrome** cannot participate. These are types of blood and bone marrow cancers.

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Verified sites

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IRCCS Humanitas Research Hospital
Rozzano, Italy
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IRCCS Ospedale Policlinico San Martino
Genoa, Italy

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Investigated drugs

Monalizumab is a medication being studied for its potential to help patients with acute myeloid leukemia or myelodysplastic syndrome. It is a type of monoclonal antibody that targets a specific protein called NKG2A. The goal of using Monalizumab in this trial is to see if it can improve the outcomes for patients who have undergone a specific type of stem cell transplant known as haploidentical transplantation. Researchers are looking at how effective and safe Monalizumab is when used in this setting.

Monalizumab

What is already known about the treatment

Monalizumab – Monalizumab is administered intravenously and is currently being studied in a Phase II clinical trial. It is primarily used for patients with acute myeloid leukemia or myelodysplastic syndrome, particularly those undergoing haploidentical transplantation with post-transplantation cyclophosphamide. The medication works by targeting the NKG2A receptor on immune cells, which helps enhance the body's immune response against cancer cells. Monalizumab is classified as a monoclonal antibody, a type of biological therapy designed to target specific proteins involved in disease processes.

Investigated diseases

Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly moves into the blood. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. Symptoms may include fatigue, fever, frequent infections, and easy bruising or bleeding. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. AML is more common in adults and can develop suddenly, requiring prompt medical attention. The exact cause of AML is not always known, but it can be influenced by genetic factors and exposure to certain chemicals or radiation.
Myelodysplastic Syndromes
Myelodysplastic Syndromes (MDS) are a group of disorders caused by poorly formed or dysfunctional blood cells. These syndromes occur when the blood-forming cells in the bone marrow are damaged, leading to a shortage of one or more types of blood cells. Common symptoms include fatigue, shortness of breath, and increased risk of infections and bleeding. MDS can vary in severity, with some cases remaining stable for years and others progressing to acute leukemia. The exact cause of MDS is often unknown, but it can be related to previous chemotherapy or radiation therapy. MDS is more common in older adults and can significantly impact quality of life.