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Study Comparing Standard Chemotherapy with CPX-351 for Adults with Newly Diagnosed Acute Myeloid Leukemia (AML) and Intermediate or Adverse Genetics

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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 type of blood cancer called Acute Myeloid Leukemia (AML). The study is specifically looking at adults who have been newly diagnosed with AML and have certain genetic characteristics that may affect their response to treatment. The trial will compare two different treatment approaches. One group of patients will receive standard intensive chemotherapy, while the other group will receive a treatment called CPX-351, which is a combination of two drugs, cytarabine and daunorubicin, delivered in a special form called liposomal. This form helps the drugs stay in the body longer and may improve their effectiveness.

The purpose of the study is to evaluate how well CPX-351 works compared to the standard chemotherapy in terms of overall survival, which means how long patients live after starting treatment. The study will involve patients receiving their assigned treatment and being monitored over time to see how they respond. Some patients may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments more accurately.

Participants in the study will receive their treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for several months, with regular check-ups to monitor the patients' health and response to the treatment. The goal is to find out if CPX-351 can improve survival rates for patients with AML compared to the standard treatment options currently available.

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, eligibility is confirmed based on specific criteria, including age, health status, and genetic assessment.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Randomization
Participants are randomly assigned to one of two groups: standard intensive chemotherapy or intensive chemotherapy with CPX-351.
Step 3
Treatment phase
For those receiving standard intensive chemotherapy, the treatment includes cytarabine and daunorubicin, administered intravenously as a solution for infusion.
Participants in the CPX-351 group receive a liposomal formulation of cytarabine and daunorubicin, also administered intravenously.
The specific dosage and frequency are determined by the study protocol and medical team.
Step 4
Monitoring and follow-up
Regular monitoring of health status and response to treatment is conducted throughout the study.
Follow-up visits are scheduled to assess overall survival and any side effects experienced during the treatment.
Step 5
End of study participation
Upon completion of the treatment phase, participants undergo final assessments to evaluate the impact of the treatment on their condition.
The study aims to determine the effectiveness of CPX-351 compared to standard chemotherapy in improving overall survival.

Who can join the trial?

13 criteria

Patients must have been newly diagnosed with **AML** (a type of blood cancer) and have specific genetic risks as defined by medical guidelines.
Female patients who can have children must agree not to get pregnant while on the study treatment and for 27 weeks after the last dose.
Women who can have children must either not have sexual intercourse or use a highly effective birth control method, like an **IUD** (a device placed in the uterus), along with another method like hormonal pills or the male partner using a condom with spermicide, during the study and for 27 weeks after.
Men must use a condom with spermicide during any sexual contact with women who can have children, even if they have had a vasectomy, and agree not to father a child during the study and for 6 months after the last dose. Their female partners must also use a highly effective birth control method.
Patients must be able to understand and willing to sign a consent form agreeing to participate in the study.
Patients must be 18 years or older, with no upper age limit.
Patients must be considered suitable for intensive chemotherapy treatment.
Patients must have an **ECOG performance status** of 2 or less, which is a measure of their ability to perform daily activities.
Patients must have a genetic assessment done in a specific laboratory.
Patients must have adequate kidney function, shown by certain levels of **serum creatinine** or **creatinine clearance**.
Patients must have adequate liver function, shown by certain levels of **bilirubin**, **AST**, **ALT**, and **ALP**, unless these levels are due to specific conditions approved by the study investigators.
Patients must not have had prior chemotherapy for acute leukemia, except for a specific medication called **hydroxyurea** for up to 14 days during diagnosis to control high white blood cell counts. Previous treatment for a related condition with certain agents is allowed.
Women who can have children must not be pregnant or nursing and must have a negative pregnancy test before starting the study.

Who cannot join the trial?

5 criteria

Patients who do not have newly diagnosed **AML**. **AML** stands for **Acute Myeloid Leukemia**, which is a type of blood cancer.
Patients who do not have intermediate- or adverse-risk genetics according to the 2017 **ELN** criteria. **ELN** stands for **European LeukemiaNet**, which provides guidelines for classifying the risk level of leukemia.
Patients who do not have **AML** with **myelodysplasia-related changes** (**AML-MRC**). **Myelodysplasia** refers to a group of disorders caused by poorly formed or dysfunctional blood cells.
Patients who do not have therapy-related **AML**. This type of **AML** occurs as a result of previous cancer treatments.
Patients who do not meet the **World Health Organization (WHO)** classification for the types of **AML** included in the study.

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Verified sites

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

Asklepios Kliniken Hamburg GmbH
Verified
Hamburg, Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Responsive
Stuttgart, Germany

Trial locations

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Investigated drugs

CPX-351
is a medication being studied for its potential to improve survival in adults with newly diagnosed acute myeloid leukemia (AML) who have intermediate or adverse genetic profiles. It is a type of chemotherapy that combines two drugs, designed to target and kill cancer cells more effectively.
Standard Intensive Chemotherapy
refers to the usual treatment regimen for AML, which involves using strong drugs to kill cancer cells. This therapy is typically used to try to achieve remission in patients by reducing the number of cancer cells in the body.

What is already known about the treatment

CPX-351 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating newly diagnosed acute myeloid leukemia (AML) with specific genetic risks. It is a combination of two chemotherapy drugs, daunorubicin and cytarabine, encapsulated in a liposomal formulation. The main therapeutic indication is for patients with AML, particularly those with intermediate or adverse genetic profiles. CPX-351 works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It is classified as an antineoplastic agent, specifically a liposomal formulation of anthracycline and cytarabine.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses quickly and requires prompt medical attention. AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML are specific subtypes that have distinct genetic and clinical features. These subtypes are classified based on genetic abnormalities and previous exposure to chemotherapy or radiation.