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Study of liposomal annamycin and cytarabine combination for patients with acute myeloid leukemia (AML) who are newly diagnosed or have not responded to previous treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies the treatment of Acute Myeloid Leukemia (AML), a type of blood and bone marrow cancer. The study examines a combination therapy using two medications: liposomal annamycin and cytarabine. This treatment approach is being investigated for patients who have either never received treatment before or whose disease has returned after initial therapy.

The purpose of this research is to determine the safety of this drug combination and find the most appropriate dose for treating AML. The treatment involves receiving both medications through intravenous infusions, which means the drugs are delivered directly into the bloodstream through a vein.

During the study, patients will receive a combination of liposomal annamycin and cytarabine as part of their cancer treatment. The medications will be given according to a specific schedule, and patients will be monitored regularly to evaluate how well they respond to the treatment and to check for any side effects. The study will assess various outcomes, including whether the treatment reduces the number of cancer cells in the bone marrow and improves blood cell counts.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your diagnosis of acute myeloid leukemia (AML) will be confirmed through bone marrow examination or blood test showing more than 5% myeloblasts.
Laboratory tests will be performed to check your liver and kidney function.
A pregnancy test will be required for women of childbearing potential within 72 hours before starting treatment.
Step 2
Treatment preparation
You must not have received any chemotherapy, radiation, or major surgery within 2 weeks before starting the study treatment.
If you have had any investigational therapy, it must have been completed at least 4 weeks before starting this treatment.
Step 3
Treatment administration
You will receive two medications through intravenous infusion:
The first medication is liposomal annamycin, a new form of cancer treatment
The second medication is cytarabine, a standard treatment for AML
Both medications will be given directly into your bloodstream through an IV line
Step 4
Monitoring and evaluation
Your bone marrow and blood will be regularly examined to check:
The number of cancer cells (blasts) in your bone marrow
Your blood cell counts, including white blood cells and platelets
Your liver and kidney function
Step 5
Treatment response assessment
Your response to treatment will be evaluated based on:
Reduction of cancer cells to less than 5% in bone marrow
Recovery of normal blood cell counts
Possibility of proceeding to stem cell transplantation if appropriate
Step 6
Follow-up period
You will need to use effective contraception during the entire study period
Women must continue contraception for 6 months after treatment ends
Men must continue contraception for 3 months after treatment ends
Regular monitoring will continue throughout the study period, which may last until June 2025

Who can join the trial?

9 criteria

You must be at least 18 years old to participate
You must have a confirmed diagnosis of Acute Myeloid Leukemia (AML) through either: - A bone marrow test, or - A blood test showing more than 5% myeloblasts (immature blood cells)
You must either: - Have not received any previous treatment for AML, or - Have had unsuccessful previous treatment with more than 5% blasts in bone marrow
If you are a woman who can become pregnant, you must have a negative pregnancy test within 72 hours before starting the study
Both men and women must use effective birth control during the study: - Women must continue birth control for 6 months after the study - Men must continue birth control for 3 months after the study
Your performance status (ability to perform daily activities) must be rated 0 to 2 on the ECOG scale, where 0 is fully active and 2 means you can still care for yourself but cannot work
You must not have received: - Any chemotherapy, radiation, or major surgery within 2 weeks before the study - Any experimental treatments within 4 weeks before the study
Your liver and kidney function tests must be within acceptable ranges: - Bilirubin levels near normal range - Liver enzymes less than 2.5 times normal - Kidney function (creatinine) less than 2 times normal
You must be able to understand and sign the consent form and follow study requirements

Who cannot join the trial?

15 criteria

Prior treatment with liposomal annamycin (an anti-cancer drug)
Known allergic reactions or severe sensitivity to annamycin or similar medications
Active heart conditions or significant heart problems in the past 6 months
Severe liver problems (liver function tests more than 3 times the normal limit)
Severe kidney problems (creatinine clearance less than 30 mL/min)
Active uncontrolled infections requiring treatment
Pregnant or breastfeeding women
Unable to give informed consent
Participation in another clinical trial within the last 30 days
Life expectancy less than 3 months
Active central nervous system involvement of leukemia
Psychiatric disorder or condition that could interfere with the study requirements
Known HIV infection
Active hepatitis B or C infection
Other types of cancer requiring treatment

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Verified sites

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
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IRCCS Azienda Ospedaliero Universitaria - Policlinico di Sant'Orsola
Bologna, Italy
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Instytut Hematologii I Transfuzjologii
Warsaw, Poland

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Investigated drugs

Liposomal Annamycin
is a medication being studied for the treatment of Acute Myeloid Leukemia (AML). It is a special form of annamycin that is enclosed in tiny fat particles called liposomes, which helps deliver the medication more effectively to cancer cells.
Cytarabine
(also known as Ara-C or cytosine arabinoside) is a chemotherapy medication commonly used to treat various types of blood cancers, including Acute Myeloid Leukemia. It works by interfering with the DNA of cancer cells, preventing them from growing and multiplying.

What is already known about the treatment

Liposomal Annamycin
A specialized form of annamycin, delivered through a liposomal formulation for intravenous administration in cancer treatment. This investigational drug belongs to the anthracycline class of chemotherapy medications and is being studied for treating Acute Myeloid Leukemia (AML). The liposomal delivery system helps to enhance the drug's effectiveness while potentially reducing side effects common to traditional anthracyclines, working by interfering with DNA replication in cancer cells to prevent their growth and spread.
Cytarabine
A widely used chemotherapy medication administered intravenously for treating various types of blood cancers, particularly Acute Myeloid Leukemia (AML). It belongs to the antimetabolite class of drugs and works by interfering with DNA synthesis to prevent cancer cell growth. Cytarabine, also known as Ara-C or cytosine arabinoside, is a standard component of many AML treatment regimens and has been well-established in medical literature as a fundamental therapy for leukemia treatment.

Investigated diseases

Acute Myeloid Leukemia - A type of blood and bone marrow cancer that develops when the body produces abnormal white blood cells called myeloblasts. These abnormal cells build up in the bone marrow and interfere with the production of normal blood cells. The disease progresses rapidly, causing a decrease in healthy blood cells, including red blood cells, platelets, and normal white blood cells. As the leukemia cells multiply, they crowd out healthy cells in the bone marrow and can spread to other parts of the body. This condition affects the body's ability to fight infections and maintain normal blood circulation.