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Study on Venetoclax, Cytarabine, and Mitoxantrone for Adults with Relapsed or Refractory Acute Myeloid Leukemia (AML) Eligible for Intensive 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 is focused on studying a type of blood cancer called acute myeloid leukemia (AML). The trial is specifically for adult patients whose AML has returned after treatment or who did not respond to initial treatments. The study involves a combination of medications: Venetoclax, Cytarabine, and Mitoxantrone. Venetoclax is taken as a film-coated tablet, while Cytarabine and Mitoxantrone are given through an intravenous infusion, which means they are administered directly into a vein.

The purpose of the study is to determine the safety and best dose of Venetoclax when used with Cytarabine and Mitoxantrone in patients who are considered fit for intensive treatment. The study will start with a phase where the dose of Cytarabine is gradually increased to find the maximum dose that can be tolerated safely. This is followed by a phase where the effectiveness of the treatment combination is assessed.

Participants in the study will receive the treatment combination and may also receive a placebo. The trial aims to find out how well the combination works and how safe it is for patients with relapsed or refractory AML. The study is expected to continue until September 2025, with the recruitment of participants having started in April 2020.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
A blood test is performed to ensure all health criteria are met before starting the trial medications.
Step 2
Start of treatment
The treatment begins with the administration of venetoclax in the form of a film-coated tablet. This medication is taken orally.
The dosage and frequency of venetoclax are determined by the study team based on individual health conditions and response to treatment.
Step 3
Combination therapy
In addition to venetoclax, mitoxantrone hydrochloride and cytarabine are administered through intravenous infusion.
Mitoxantrone hydrochloride and cytarabine are given at fixed doses, and the frequency is determined by the study protocol.
Step 4
Monitoring and adjustments
Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes frequent health check-ups and blood tests.
Based on the results, adjustments to the medication dosage may be made to ensure the best possible outcome.
Step 5
End of treatment
The treatment phase concludes as per the study timeline or upon achieving the desired health outcomes.
A final assessment is conducted to evaluate the overall response to the treatment and to document any side effects experienced during the trial.

Who can join the trial?

16 criteria

Must provide a signed informed consent form.
Must have been diagnosed with acute myeloid leukemia (AML) according to WHO criteria, but not a type called APL.
Must have experienced a relapse after the first or second complete remission, including relapse after a type of treatment called allogeneic stem cell transplantation.
For the expansion phase only: Must have primary refractory disease, meaning the leukemia did not respond to 1-2 cycles of standard induction chemotherapy. This is defined by having a certain percentage of leukemia cells (myeloid blasts) in the blood after treatment.
Must be between 18 and 75 years old.
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Must be fit for intensive chemotherapy, which means:
- Having an ECOG performance status of 0-2, indicating a life expectancy of more than 3 months.
- Having adequate liver function, with specific blood test results (ALAT/ASAT/Bilirubin) not more than 2.5 times the upper limit of normal.
- Having adequate kidney function, with a creatinine level less than 1.5 times the upper limit of normal or a creatinine clearance of at least 50 mL/min.
- Must not have a fever and must be stable in terms of blood pressure and heart rate for at least 72 hours before starting the study medication.
- Male participants must agree to use protection during sex and avoid donating sperm from the time of signing the consent form until 30 days after the last dose of the study drug.
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  Female participants must meet one of the following conditions:
  - Be post-menopausal, which means no menstrual periods for 12 months naturally or 6 months with a specific hormone level (FSH > 40 U/ml).
  - Have had surgery to remove both ovaries, with or without removal of the uterus, at least 6 weeks ago.
  - If of childbearing potential, must have a negative pregnancy test within 7 days before the first dose of the study drug.
  - Must use a reliable method of contraception with a failure rate of less than 1% from the time of signing the consent form until 30 days after the last dose of the study drug. This includes methods like implants, depots, oral contraceptives, or an intrauterine device (IUD). Note: It is not known if the study drug affects hormonal contraceptives, so a barrier method should be used in addition to hormonal methods.
  - Practice sexual abstinence.
  - Have a partner who has had a vasectomy.

Who cannot join the trial?

5 criteria

Patients who have not experienced a first or second relapse of acute myeloid leukemia (AML) after intensive chemotherapy, including a stem cell transplant.
Patients who are not considered fit for intensive salvage treatment, which is a strong treatment given when the initial treatment does not work.
Patients who have not been diagnosed with primary refractory AML, meaning their leukemia did not respond to the first standard treatment.
Patients who are not adults, as the study is only for adult participants.
Patients who are not eligible for intensive treatment due to other health conditions or factors.

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Verified sites

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Goethe University Frankfurt
Frankfurt, Germany
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Philipps-Universitaet Marburg
Marburg, Germany
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Technische Universitaet Dresden
Dresden, Germany

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Investigated drugs

Cytarabine
is a medication used in this trial to help treat a type of blood cancer called acute myeloid leukemia (AML). It works by interfering with the growth of cancer cells, which can help to slow down or stop the progression of the disease. In this trial, cytarabine is being used in combination with other medications to see if it can be more effective in treating patients whose cancer has returned or has not responded to previous treatments.
Mitoxantrone
is another medication used in this trial. It is a type of chemotherapy that helps to kill cancer cells by damaging their DNA. This can prevent the cancer cells from growing and dividing. Mitoxantrone is used in combination with other drugs in this study to see if it can improve the treatment outcomes for patients with relapsed or refractory AML.
Venetoclax
is a medication that targets a specific protein in cancer cells, which can help to trigger the death of these cells. It is used in this trial to see if it can enhance the effects of the other chemotherapy drugs, cytarabine and mitoxantrone, in treating AML. The goal is to find the safest and most effective dose of venetoclax when used with these other medications.

What is already known about the treatment

Cytarabine
Cytarabine is administered as an injection into a vein, typically used in combination with other medications for treating certain types of leukemia, including acute myeloid leukemia (AML). It is well-established in medical literature as a chemotherapy agent. Its main therapeutic use is to treat AML, especially in patients who have relapsed or are resistant to initial treatments. At the molecular level, cytarabine works by interfering with DNA synthesis, which prevents cancer cells from growing and dividing. It is classified as an antimetabolite in pharmacology.
Mitoxantrone
Mitoxantrone is given as an intravenous injection and is used in combination with other drugs to treat certain types of cancer, including AML. It is recognized in medical literature as a chemotherapy drug. The primary therapeutic indication for mitoxantrone is to treat AML, particularly in patients who have not responded to other treatments. It works by disrupting DNA replication and repair, leading to cell death. Mitoxantrone is classified as an anthracenedione in pharmacology.
Venetoclax
Venetoclax is taken orally in the form of tablets and is used in combination with other medications to treat certain blood cancers, including AML. It is a newer addition to medical literature and is being studied for its effectiveness and safety. Venetoclax is primarily used for patients with AML who have relapsed or are resistant to standard treatments. It works by inhibiting a protein called BCL-2, which helps cancer cells survive, thereby promoting their death. Venetoclax is classified as a BCL-2 inhibitor in pharmacology.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow and results in the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow and interfere with the production of normal blood cells. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. Symptoms often include fatigue, fever, frequent infections, and easy bruising or bleeding. The disease can progress quickly, requiring prompt medical attention. It is most common in adults and can occur at any age.