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Study on Personalized Treatment for Acute Myeloid Leukemia Using Cladribine, Daunorubicin, Cytarabine, and Drug Combinations for Specific Patient Groups

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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 Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study aims to explore the effectiveness of different treatment combinations for patients with AML. The treatments being tested include a combination of medications such as Cladribine, Daunorubicin, Cytarabine (also known as cytosine arabinoside), Gemtuzumab Ozogamicin, Midostaurin, and Venetoclax. These medications are used to target and kill cancer cells in the body.

The purpose of the study is to compare the effectiveness of these treatment combinations in improving the condition of patients with AML. The study will involve different groups of patients receiving different combinations of these medications. For example, one group will receive Cladribine with Daunorubicin, Cytarabine, and Gemtuzumab Ozogamicin, while another group will receive Cladribine with Daunorubicin, Cytarabine, and Midostaurin. Another group will receive Venetoclax with Cladribine, Daunorubicin, and Cytarabine. Some patients may receive a placebo as part of the study.

Participants in the study will receive their assigned treatment over a period of time, and their health will be monitored to assess the effectiveness of the treatment. The study will help determine which combination of medications works best for different types of AML patients, including those with specific genetic mutations like the FLT3 gene mutation. The results of this study could lead to more personalized and effective treatment strategies for patients with AML.

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 such as age, general health condition, and diagnosis of acute myeloid leukemia.
Consent is required to participate, including agreement to use effective contraception during the study.
Step 2
Treatment assignment
Participants are assigned to different treatment groups based on specific genetic markers and health conditions.
The treatment protocols include combinations of medications such as cladribine, daunorubicin, cytarabine, midostaurin, venetoclax, and gemtuzumab ozogamicin.
Step 3
Induction treatment
The induction treatment phase involves receiving specific drug combinations intravenously or orally, depending on the assigned protocol.
For example, the DAC+GO protocol includes cladribine, daunorubicin, cytarabine, and gemtuzumab ozogamicin for certain patients.
Step 4
Monitoring and assessments
Regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment.
Event-free survival and other health outcomes are measured to determine the success of the treatment.
Step 5
Completion of treatment
The study is expected to continue until November 2027, with ongoing assessments and follow-ups.
Participants may undergo additional treatments or procedures based on their response to the initial treatment.

Who can join the trial?

7 criteria

Must have been diagnosed with **Acute Myeloid Leukemia** according to the WHO 2016 criteria. This is a type of blood cancer.
Must be between the ages of 18 and 65 years old.
Must have a general health condition score of 2 or less on the **ECOG scale**. This scale measures how well you can perform daily activities.
Must have a score of 3 or less on the **HCT-CI comorbidity index**. This index assesses other health conditions you might have.
Must provide informed, written consent to participate in the study.
Must agree to use effective contraception during the study. This applies to both women and men.
Women of childbearing age must have a negative pregnancy test, either from blood (serum) or urine.

Who cannot join the trial?

10 criteria

Patients who are not diagnosed with Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who do not meet the specific genetic criteria required for the study. This may include certain gene mutations related to AML.
Patients who are not able to follow the study protocol or procedures. This means they must be able to attend all required appointments and follow instructions.
Patients who have other medical conditions that could interfere with the study. This includes conditions that might affect the safety or effectiveness of the treatment being tested.
Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Patients who are participating in another clinical trial. Being in more than one study at a time can affect the results and safety.
Patients who have had certain treatments recently that could interfere with the study. This includes specific medications or therapies.
Patients who have allergies or reactions to the study medications. This is to prevent any harmful side effects.
Patients who are unable to give informed consent. This means they must understand the study and agree to participate willingly.

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Verified sites

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

Verified
Instytut Hematologii I Transfuzjologii
Warsaw, Poland
Verified
Pomeranian Medical University
Szczecin, Poland
Responsive
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland

Trial locations

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Investigated drugs

Cladribine
is a medication used in this trial as part of different treatment combinations for patients with acute myeloid leukemia (AML). It is included in protocols to help improve the effectiveness of the treatment by targeting cancer cells.
Daunorubicin
is a chemotherapy drug that is used in combination with other medications in this trial. It works by slowing or stopping the growth of cancer cells.
Cytosine Arabinoside
, also known as cytarabine, is another chemotherapy medication used in the trial. It helps to kill cancer cells and is a key part of the treatment combinations being tested.
Gemtuzumab Ozogamicin
is an antibody-drug conjugate used in one of the treatment protocols for patients with a specific type of AML. It targets cancer cells and delivers a toxic substance to help destroy them.
Midostaurin
is a medication used in the trial for patients with AML who have certain genetic mutations. It works by inhibiting specific proteins that promote cancer cell growth.
Venetoclax
is included in one of the treatment combinations for AML patients. It helps to induce cancer cell death by targeting proteins that allow cancer cells to survive.

What is already known about the treatment

Cladribine
Cladribine is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Acute Myeloid Leukemia (AML). It is often used in combination with other drugs like daunorubicin and cytosine arabinoside. Cladribine works by interfering with the DNA synthesis of cancer cells, leading to their death. It is classified as an antimetabolite, which is a type of chemotherapy drug.
Daunorubicin
Daunorubicin is given through intravenous infusion and is a well-established medication in the treatment of various types of leukemia, including AML. It is used in combination therapies to enhance its effectiveness. Daunorubicin works by intercalating DNA strands, thereby inhibiting the replication of cancer cells. It belongs to the class of drugs known as anthracyclines.
Cytosine Arabinoside
Also known as cytarabine, this medication is administered intravenously and is a cornerstone in the treatment of AML. It is used in combination with other drugs to improve treatment outcomes. Cytosine arabinoside acts by inhibiting DNA synthesis, which prevents cancer cells from multiplying. It is classified as an antimetabolite.
Gemtuzumab Ozogamicin
This medication is administered intravenously and is used in the treatment of AML, particularly in patients with specific genetic markers. It is an antibody-drug conjugate that targets CD33-positive cancer cells, delivering a cytotoxic agent directly to them. Gemtuzumab ozogamicin is classified as a monoclonal antibody.
Midostaurin
Midostaurin is taken orally and is used in combination with other drugs for treating AML, especially in patients with FLT3 gene mutations. It works by inhibiting multiple kinases, which are enzymes involved in the growth and survival of cancer cells. Midostaurin is classified as a kinase inhibitor.
Venetoclax
Venetoclax is administered orally and is being investigated for its use in AML treatment. It is often combined with other chemotherapy agents to enhance its efficacy. Venetoclax works by inhibiting the BCL-2 protein, which helps cancer cells survive, thereby promoting their death. It is classified as a BCL-2 inhibitor.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) 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. As the disease progresses, it can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. AML can occur at any age but is more common in adults. The disease is classified into different subtypes based on genetic and chromosomal abnormalities. The progression of AML can vary, with some cases advancing quickly while others may develop more slowly.