Study of MP0533 for Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Using Sodium Dihydrogen Phosphate Dihydrate, Polysorbate 20, and Sodium Chloride

2 1 1 1

What is this study about?

This clinical trial is focused on studying two types of blood cancers: acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). These are serious conditions where the bone marrow does not produce blood cells properly. The treatment being tested in this study is called MP0533, which is given as a solution through an infusion into the veins. This treatment contains substances like sodium dihydrogen phosphate dihydrate, polysorbate 20, and sodium chloride.

The purpose of the study is to explore the safety and how well patients tolerate MP0533, as well as to find the best dose to use in future studies. The study will also look at how effective the treatment is in fighting the cancer. Participants will receive the treatment and be monitored closely to see how their bodies respond. The study will take place over several phases, starting with a small number of patients to determine the safest dose, and then expanding to include more patients to further assess the treatment’s effects.

Throughout the study, researchers will keep track of any side effects and changes in the patients’ health. The goal is to gather information that could lead to new treatment options for people with AML and MDS. This study is an important step in understanding how MP0533 can be used to help patients with these challenging conditions.

1 joining the study

Upon joining the study, the patient will have signed and dated a written informed consent form. This confirms understanding and agreement to participate in the study.

The patient must have a diagnosis of relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and meet specific health criteria, including adequate kidney and liver function.

2 initial assessment

An initial assessment will be conducted to evaluate the patient’s health status. This includes checking the performance status and life expectancy, as well as ensuring the patient meets all inclusion criteria.

3 treatment administration

The patient will receive the study medication, MP0533, which is a solution for infusion administered intravenously.

The dosage and frequency will be determined during the study, with the aim to find the safest and most effective dose.

4 monitoring and evaluation

Throughout the study, the patient will be closely monitored for any side effects or changes in health status. This includes regular laboratory tests and vital sign checks.

The study will assess the safety and tolerability of MP0533, as well as its effectiveness in treating the patient’s condition.

5 completion of treatment cycle

At the end of each treatment cycle, the patient’s response to the medication will be evaluated. This includes measuring the overall response rate and any changes in the condition.

The study aims to determine the best overall response, which may include complete remission or partial remission.

6 follow-up

After completing the treatment cycles, the patient will continue to be monitored for any long-term effects or changes in their condition.

The study will track the duration of response and overall survival, as well as any progression to further treatments such as stem cell transplantation.

Who Can Join the Study?

The patient must have signed and dated a written agreement to participate in the study before any study procedures are done.
The patient must have a diagnosis of relapsed/refractory acute myeloid leukemia (AML) or relapsed/refractory myelodysplastic syndrome (MDS/AML), based on specific medical guidelines.
The patient must be 18 years or older on the day they sign the agreement to participate.
The patient must have a performance status of 0 to 2, which is a measure of their ability to carry out daily activities.
The patient must have a life expectancy of at least 12 weeks, as judged by the study doctor.
The patient must have adequate kidney and liver function. This means:
- The kidneys must be able to filter blood at a rate greater than 40 mL/min, unless the condition is related to AML or MDS.
- The level of bilirubin in the blood, a substance made by the liver, must be no more than 2.5 times the normal limit, unless related to AML, MDS, or a condition called Gilbert’s syndrome.
- The levels of certain liver enzymes, AST and ALT, must be no more than 3 times the normal limit, unless related to AML or MDS.
The patient must have a white blood cell count of 15G/L or less on the day they receive the trial drug. A medication called hydroxyurea is allowed before this.
If the patient is a woman who can have children or a man, they must use highly effective birth control during the study.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied.
Patients who have not recovered from previous treatments or surgeries.
Patients with severe heart problems.
Patients with uncontrolled infections.
Patients who are pregnant or breastfeeding.
Patients who have a history of other serious medical conditions that could interfere with the study.
Patients who are unable to follow the study procedures.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Adoeglziu Uza	Amsterdam	The Netherlands
Ahfougxiww Ptoeasza Hdskhdjv Dg Pgeit	Paris	France
Egkzotb Ulluydjtjslr Mgbvvar Ctdfkvl Rrafgokbb (gjsxhwi Mco	Rotterdam	The Netherlands
Unycgflcxnvg Mkuyolu Ctrswkf Guhgqxgbx	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.04.2023
Lithuania	Not recruiting	03.04.2023
The Netherlands	Not recruiting	03.04.2023

Trial locations

Investigated drugs:

MP0533 is an experimental medication being studied for its potential to treat patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The trial aims to determine how safe and tolerable this medication is for patients, as well as to find the most effective dose. Researchers are also looking at how well MP0533 can fight leukemia in these patients.

Investigated diseases:

Acute Myeloid Leukemia (AML) – This is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect 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 known for its aggressive nature and requires prompt medical attention.

Myelodysplastic Syndrome (MDS) – This is a group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when the blood-forming cells in the bone marrow are damaged, leading to a shortage of one or more types of blood cells. People with MDS may experience symptoms such as fatigue, shortness of breath, and increased risk of infections or bleeding. The condition can vary in severity and may progress to acute myeloid leukemia in some cases. MDS is often diagnosed through blood tests and bone marrow examinations.

Trial ID:

2023-505259-39-00

Protocol code:

MP0533-CP101

NCT ID:

NCT05673057

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of MP0533 for Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Using Sodium Dihydrogen Phosphate Dihydrate, Polysorbate 20, and Sodium Chloride

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?