Not yet recruitingRare disease

Study on the Safety and Effects of AB8939 and Azacitidine for Patients with Relapsed or Refractory Acute Myeloid Leukemia

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 studying a treatment for patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). These are types of blood cancers that affect the bone marrow, where blood cells are made. The study is testing a new medication called AB8939, which is given as a daily intravenous injection. The purpose of the study is to understand how safe and tolerable this medication is for patients who have AML or MDS that has returned or not responded to previous treatments.

During the trial, participants will receive the medication AB8939 to see how their bodies react to it and to determine the best dose to use in future studies. Another medication, Vidaza, which contains the active substance Azacitidine, may also be used in the study. Vidaza is a powder that is mixed into a suspension for injection and is used to treat certain types of blood disorders. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients.

The study will monitor participants over a period of time to observe any side effects and to measure how well the treatment works in controlling the disease. The goal is to find the most effective and safe dose of AB8939 for patients with these conditions. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather important information about the treatment's effects.

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
Joining the study
Upon joining the study, you will be required to sign a written informed consent form. This form confirms that you understand the study procedures and agree to participate.
You will need to meet specific criteria, such as having a documented diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and being in the appropriate line of treatment.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you are eligible for the trial. This includes checking your organ function and overall health status.
You must not have severe dysfunction of the heart, lungs, liver, kidneys, or nervous system, and you should not have an immune deficiency.
Step 3
Treatment administration
The treatment involves the administration of AB8939 through daily intravenous injections. The dosage and duration will be determined based on your response and tolerance.
You may also receive Vidaza, which is administered either intravenously or subcutaneously, depending on the specific requirements of the study.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring will be conducted to assess your response to the treatment and any side effects. This includes blood tests and possibly bone marrow biopsies.
The study aims to determine the safety and effectiveness of the treatment, as well as the appropriate dosage.
Step 5
Completion of the trial
Upon completion of the treatment period, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects.
The study is expected to conclude by the end of 2025, but your participation may end earlier depending on your individual treatment plan.

Who can join the trial?

11 criteria

Patients must have a documented diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Patients with AML should be in their second or third line of treatment, depending on their eligibility for high-dose chemotherapy in the first line. Patients with MDS should be in their second or third line of treatment and have a high risk based on a specific scoring system.
Patients should not be eligible for hematopoietic stem cell transplantation (HSCT) at the time of joining the study. HSCT is a procedure to replace damaged or destroyed bone marrow with healthy bone marrow stem cells.
Patients must be expected to complete the treatment period, according to the investigator's opinion.
Patients must be male or non-pregnant female and at least 18 years old at the time of signing the informed consent.
Patients must have an ECOG performance status of 0 or 1. This is a scale used to assess how a patient's disease is progressing, including their level of functioning and ability to care for themselves.
Patients must have adequate organ function without severe dysfunction of the heart, lungs, liver, kidneys, or nervous system, and no immune deficiency.
If the disease is not rapidly progressing, there should be at least 14 days between the last treatment and the start of the study treatment.
Patients must have adequately recovered from the side effects of previous therapy, with side effects reduced to a maximum of Grade 1. This refers to a mild level of side effects based on a standard grading system.
Patients must be able to understand, sign, and date the written informed consent form before any study-specific procedures.
Patients must be able and willing to comply with study procedures, including bone marrow biopsies.

Who cannot join the trial?

10 criteria

Patients with any other active cancer cannot participate.
Patients who have had a heart attack or severe heart problems in the last 6 months are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe liver disease are excluded.
Patients with severe kidney disease cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients with a known allergy to the study drug or similar drugs cannot join.
Patients who have received another experimental drug within the last 4 weeks are excluded.
Patients with active infections that require treatment are not eligible.
Patients with a history of drug or alcohol abuse in the last 6 months cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

EVAGGELISMOS"General Hospital of Athens
Verified
Athens, Greece
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Hospital Universitario De Navarra
Verified
Pamplona, Spain

Trial locations

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Investigated drugs

AB8939 is a medication being tested in this clinical trial for patients with a type of blood cancer called Acute Myeloid Leukemia (AML) that has come back or has not responded to previous treatments. This medication is given through an intravenous (IV) infusion, which means it is delivered directly into the bloodstream through a vein. The main goal of using AB8939 in this trial is to find out how safe it is for patients and to determine the best dose that can be given without causing severe side effects. Researchers are also looking to see how well it works in treating the cancer. By participating in this trial, patients will help doctors understand more about the potential benefits and risks of AB8939 for treating AML.

What is already known about the treatment

AB8939 – AB8939 is administered through daily intravenous infusions, meaning it is delivered directly into the bloodstream via a vein. Currently, this medication is being studied in clinical trials and is not yet widely available in medical practice. It is primarily being investigated for its potential to treat patients with relapsed or refractory Acute Myeloid Leukemia (AML). At the molecular level, AB8939 works by targeting and disrupting specific processes within cancer cells, which may help to stop their growth and spread. It falls under the pharmacological classification of anti-cancer agents, specifically designed to combat leukemia.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression of the disease requires prompt medical attention to manage symptoms and complications.