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Study of Venetoclax and Decitabine for Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

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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 testing a combination of two treatments: Venetoclax and Decitabine. Venetoclax is taken as a tablet, while Decitabine is given through an infusion, which means it is delivered directly into the bloodstream. The purpose of the study is to see if this combination can help patients whose AML has returned or has not responded to previous treatments.

Participants in the study will receive the combination of Venetoclax and Decitabine over a period of time. The study will monitor how well the treatment works in reducing cancer cells in the bone marrow, which is the soft tissue inside bones where blood cells are made. The study will also look at the safety of the treatment and any side effects that may occur. The goal is to achieve a state called hematologic remission, where there are fewer than 5% cancer cells in the bone marrow after one or two cycles of treatment.

Throughout the study, participants will be closely monitored for any changes in their health, including their blood cell counts and any infections that may require treatment. The study will also assess the quality of life of participants and how quickly they can recover from the treatment. This research aims to provide more information on the effectiveness and safety of using Venetoclax and Decitabine together for treating relapsed or refractory AML.

The research process

The trial runs in 7 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 an informed consent document. This document confirms that you understand the study and agree to participate.
You must be at least 18 years old and have a diagnosis of acute myeloid leukemia (AML) that meets specific criteria.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your health status and ensure you meet all the study requirements.
This assessment may include a review of your medical history, physical examination, and laboratory tests.
Step 3
Treatment cycle 1
You will begin the first cycle of treatment with two medications: decitabine and venetoclax.
Decitabine will be administered as an intravenous infusion. The dosage and frequency will be determined by the study protocol.
Venetoclax will be taken orally in the form of film-coated tablets. The dosage and frequency will be specified by the study protocol.
Step 4
Monitoring and assessments
Throughout the treatment cycle, regular monitoring will occur to assess your response to the medications and to check for any side effects.
This may include blood tests, bone marrow assessments, and other evaluations as needed.
Step 5
Treatment cycle 2
If necessary, a second cycle of treatment with decitabine and venetoclax may be administered.
The administration and monitoring process will be similar to the first cycle.
Step 6
Follow-up and evaluation
After completing the treatment cycles, follow-up assessments will be conducted to evaluate the effectiveness of the treatment.
These assessments will include checking for hematologic remission, which means having less than 5% residual bone marrow blasts.
Step 7
End of trial
At the end of the trial, a final evaluation will be performed to assess your overall health and any long-term effects of the treatment.
You will be asked to refrain from donating blood for 28 days after discontinuing the study treatment.

Who can join the trial?

11 criteria

Diagnosis of acute myeloid leukemia (AML) according to WHO criteria, including all subtypes.
Refractory to induction chemotherapy, meaning the initial treatment did not work, with at least 5% cancer cells remaining in the bone marrow after the first cycle of chemotherapy.
Relapse of AML or a specific type of myelodysplastic syndrome (MDS EB2) after chemotherapy, with at least 5% cancer cells in the bone marrow.
Must be 18 years or older at the time of signing the informed consent.
Must understand and voluntarily sign an informed consent document before any study-related assessments or procedures.
Able to follow the study visit schedule and other study requirements.
Assessed by an experienced blood specialist (hematologist) as fit for aggressive chemotherapy and transplantation.
No known history of chronic lung disease and no difficulty breathing. If there is a history, lung function tests must show adequate results.
Willing to use highly effective birth control methods during treatment and for 3 months (for males) and 6 months (for females) after treatment ends. Female participants using hormonal contraceptives should also use a barrier method.
Agree not to donate blood while on the study drug and for 28 days after stopping the study treatment.
Agree not to share medication with others.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides acute myeloid leukemia (AML) cannot participate.
Patients who have had a stem cell transplant in the past cannot participate.
Patients with uncontrolled infections cannot participate.
Patients with severe heart problems cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients with a history of severe allergic reactions to the study drugs cannot participate.
Patients with significant liver or kidney disease cannot participate.
Patients who have received certain treatments for AML in the past cannot participate.
Patients with a history of other serious medical conditions that might interfere with the study cannot participate.

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Universitaetsklinikum Tuebingen AöR
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Tuebingen, Germany

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Investigated drugs

Venetoclax
is a medication used in this clinical trial to help treat a type of blood cancer called acute myeloid leukemia (AML) that has come back or has not responded to previous treatments. It works by targeting and blocking a specific protein in cancer cells that helps them survive. By blocking this protein, Venetoclax can help kill the cancer cells and reduce the number of cancer cells in the body.
Decitabine
is another medication used in this trial, which is also aimed at treating relapsed or refractory AML. Decitabine works by interfering with the DNA of cancer cells, which can stop them from growing and multiplying. This can help reduce the number of cancer cells in the bone marrow and improve blood cell counts, potentially leading to remission of the disease.

What is already known about the treatment

Venetoclax
Venetoclax is taken orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating acute myeloid leukemia (AML). It is primarily used for patients with relapsed or refractory AML, meaning the disease has returned or is not responding to treatment. Venetoclax works by targeting and inhibiting a protein called BCL-2, which helps cancer cells survive; by blocking this protein, the medication encourages the cancer cells to die. It is classified as a BCL-2 inhibitor in pharmacology.
Decitabine
Decitabine is administered through an intravenous infusion, meaning it is given directly into a vein, and is being evaluated in clinical trials for its role in treating acute myeloid leukemia (AML). It is used for patients whose AML has returned or is not responding to other treatments. Decitabine works by incorporating into the DNA of cancer cells and interfering with their growth and division, leading to cell death. It is classified as a hypomethylating agent in pharmacology.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The disease progresses quickly and can lead to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the abnormal cells multiply, they can spread to other parts of the body, including the liver, spleen, and lymph nodes. The progression of AML can vary, with some cases advancing rapidly while others may progress more slowly. The disease requires careful monitoring to manage its impact on the body.