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Study of Magrolimab and Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Stem Cell 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 treatments for two blood-related diseases: Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Neoplasia. The study will explore the effects of a treatment combination that includes a medication called Magrolimab, which is given as a solution through a vein, along with intensive chemotherapy. The chemotherapy may include drugs like Cytarabine and Daunorubicin, which are also administered through a vein. The purpose of the study is to evaluate the effectiveness of this treatment combination in patients who are newly diagnosed with AML and are considered to have an intermediate or poor risk according to specific medical guidelines. These patients are also intended to undergo a procedure called allogeneic stem cell transplantation, which involves replacing diseased bone marrow with healthy cells from a donor.

The study will follow a specific course where participants will receive the treatment over a period of time, with the aim of achieving the best possible response during the initial phase of chemotherapy. This phase is known as induction chemotherapy, which is the first step in treating these diseases. The study will monitor the participants' health and response to the treatment, including any side effects they may experience. The goal is to determine how well the treatment works in achieving complete remission, which means the absence of disease symptoms, and to assess the overall survival and quality of life of the participants.

Participants will be closely observed throughout the study to gather information on their progress and any changes in their condition. The study will also collect data on the rate of successful stem cell transplants and the impact of the treatment on the participants' quality of life. This information will help researchers understand the potential benefits and risks of using Magrolimab in combination with intensive chemotherapy for treating Acute Myeloid Leukemia and High-risk Myelodysplastic Neoplasia.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This may include medical history review, physical examination, and laboratory tests.
Step 3
Induction therapy cycle 1
You will begin the first cycle of induction therapy. This involves receiving medications through an intravenous infusion. The medications include Magrolimab, Cytarabine, and Daunorubicin. The specific dosage and frequency will be determined by the study team.
The goal of this phase is to achieve a complete remission or significant reduction in disease symptoms.
Step 4
Evaluation after cycle 1
After completing the first cycle of induction therapy, your response to the treatment will be evaluated. This may involve additional tests and assessments to determine the effectiveness of the therapy.
Step 5
Induction therapy cycle 2
If necessary, a second cycle of induction therapy may be administered. This will follow the same procedure as the first cycle, with the same medications and method of administration.
Step 6
Evaluation after cycle 2
Following the second cycle, another evaluation will be conducted to assess your response to the treatment. The study team will determine if further treatment is needed.
Step 7
Consolidation therapy
If you achieve remission, you may proceed to consolidation therapy. This phase aims to maintain remission and prevent relapse. The specific treatment plan will be discussed with you by the study team.
Step 8
Follow-up and monitoring
Throughout the study, regular follow-up visits will be scheduled to monitor your health and any side effects. You will be asked to complete questionnaires to assess your quality of life during the trial.
Step 9
Completion of study participation
At the end of your participation in the study, a final assessment will be conducted. You will receive information about your treatment outcomes and any further steps if needed.

Who can join the trial?

5 criteria

Must have a diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome with increased blasts (MDS-IB-2) according to the World Health Organization (WHO) 2022 criteria.
Must be classified as having an intermediate or adverse risk according to the European LeukemiaNet (ELN) 2022 guidelines. This applies to both MDS and AML.
Must plan to undergo intensive chemotherapy, which could be either CPX-351 or a regimen known as "7+3", followed by a procedure called allogeneic hematopoietic stem cell transplantation (HSCT). This is a type of bone marrow transplant using cells from a donor.
Must be within the age range of 18 to 65 years old.
Both male and female participants are eligible.

Who cannot join the trial?

2 criteria

Patients with **high-risk myelodysplastic neoplasia** cannot participate. This is a condition where the bone marrow does not produce enough healthy blood cells.
Patients with **acute myeloid leukemia** are excluded. This is a type of cancer that affects the blood and bone marrow.

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Verified sites

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Goethe University Frankfurt
Frankfurt, Germany
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Martin-Luther-Universitaet Halle-Wittenberg
Halle (Saale), Germany
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Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Stuttgart, Germany

Trial locations

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Investigated drugs

Magrolimab
is a medication that helps the immune system find and destroy cancer cells. It works by blocking a specific signal that cancer cells use to hide from the immune system. In this trial, Magrolimab is used alongside chemotherapy to treat patients with a type of blood cancer called acute myeloid leukemia (AML). The goal is to improve the effectiveness of the chemotherapy and help patients achieve a better response to the treatment.
Intensive Chemotherapy
is a treatment that uses strong drugs to kill cancer cells. It is called "intensive" because it involves higher doses or a combination of drugs to aggressively target the cancer. In this trial, intensive chemotherapy is used to treat patients with AML, aiming to reduce the number of cancer cells in the body and prepare patients for a possible stem cell transplant.

What is already known about the treatment

Magrolimab – Magrolimab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating high-risk myelodysplastic neoplasia and acute myeloid leukemia, particularly in patients who are newly diagnosed and considered to have intermediate or poor risk. The medication works by targeting and blocking a specific protein on cancer cells, which helps the immune system recognize and destroy these cells. Magrolimab is classified as an anti-cancer agent, specifically a monoclonal antibody, which is a type of drug designed to target specific proteins in the body.

Investigated diseases

High-risk Myelodysplastic Neoplasia
This disease involves a group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when something goes wrong in the bone marrow, where blood cells are produced. Over time, the bone marrow becomes filled with abnormal cells, leading to a decrease in the number of healthy blood cells. This can result in symptoms such as fatigue, infections, and easy bruising or bleeding. The condition can progress to more severe forms of blood disorders. In some cases, it may evolve into acute myeloid leukemia.
Acute Myeloid Leukemia
This 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. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. Symptoms often include fatigue, fever, frequent infections, and easy bruising or bleeding. The disease progresses rapidly and requires prompt medical attention. It is one of the most common types of leukemia in adults.