Not recruitingRare disease

Study of Venetoclax and Decitabine for Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia Eligible for Stem Cell Transplant

Verified siteRegistered drugNo placebo

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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 treatment for , a type of cancer that affects the blood and bone marrow. The study involves a combination of two medications: and . Venetoclax is taken as a tablet, while Decitabine is given through an infusion, which means it is administered directly into the bloodstream.

The purpose of the study is to evaluate how effective this combination treatment is for elderly patients who have been newly diagnosed with AML and are eligible for a procedure called allogeneic stem cell transplantation. This procedure involves replacing diseased bone marrow with healthy stem cells from a donor. The study aims to see how many patients can successfully undergo this procedure after receiving the combination treatment.

Participants in the study will receive the combination of Venetoclax and Decitabine over a period of time. The study will monitor the patients' response to the treatment and their ability to proceed to the stem cell transplantation. The trial will also observe the long-term outcomes of the transplantation, including any complications and the overall survival of the patients. The study is expected to continue until 2025.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Introduction to the study
Upon joining the study, the patient receives an overview of the trial's purpose and procedures. The study focuses on evaluating the effectiveness of a combination of two medications, venetoclax and decitabine, for treating elderly patients with newly diagnosed acute myeloid leukemia (AML).
Step 2
Medication administration
The patient begins treatment with venetoclax, which is administered orally in the form of 100 mg film-coated tablets. The dosage and frequency are determined by the study protocol and the patient's specific condition.
In addition to venetoclax, the patient receives decitabine, which is administered intravenously. This involves a solution for infusion prepared from a 50 mg powder. The frequency and duration of administration are specified in the study protocol.
Step 3
Monitoring and evaluation
Throughout the trial, the patient's response to the treatment is closely monitored. This includes regular assessments to evaluate the effectiveness of the medication combination and to check for any side effects.
The primary goal is to determine the proportion of patients who achieve a state suitable for allogeneic stem cell transplantation (allo-SCT) after treatment with the venetoclax and decitabine combination.
Step 4
Follow-up assessments
The study includes follow-up assessments to track the patient's progress after the initial treatment phase. These assessments occur at various intervals, such as 30 days, 100 days, 1 year, and 2 years post-transplant, if applicable.
The follow-up focuses on evaluating the long-term outcomes, including the incidence of graft failure, overall survival, and disease-free survival.

Who can join the trial?

11 criteria

Patients must be between 60 and 74 years old.
Must have a diagnosis of Acute Myeloid Leukemia (AML) and be eligible for a type of treatment called allo-SCT, which involves receiving stem cells from a donor.
Must be classified as high or intermediate risk according to a specific guideline called ELN.
White blood cell count must be less than 25 billion per liter. A medication called Hydroxyurea can be used to help meet this requirement.
Liver function must be adequate, meaning bilirubin levels should be no more than twice the normal limit, and liver enzymes ALT and AST should be no more than 2.5 times the normal limit.
Kidney function must be adequate, with a creatinine clearance of at least 50 milliliters per minute. This measures how well the kidneys are working.
Must have an ECOG Performance Status of 2 or less, which is a scale used to assess how a disease affects a patient's daily living abilities.
Men participating in the study with partners who can become pregnant must agree to use a reliable barrier method of contraception during the trial.
Women who can become pregnant must use highly effective contraception for at least one month after the last dose of the study medication VEN and for the duration specified for DEC in the European guidelines.
Must be willing and able to follow all the study requirements and attend all scheduled visits.
Must provide written and signed informed consent, which means agreeing to participate after being fully informed about the study.

Who cannot join the trial?

6 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 younger than 60 years old or older than 75 years old.
Patients who are not eligible for allo-SCT. Allo-SCT stands for allogeneic stem cell transplant, a procedure where a patient receives blood-forming stem cells from a donor.
Patients who are not newly diagnosed with AML.
Patients who are not treated with the combination of Venetoclax and Decitabine. Venetoclax and Decitabine are medications used to treat AML.
Patients who do not achieve CR, CRi, or MLFS after treatment. CR stands for complete remission, CRi stands for complete remission with incomplete blood count recovery, and MLFS stands for morphologic leukemia-free state.

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Verified sites

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

ASST Grande Ospedale Metropolitano Niguarda
Verified
Milan, Italy
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Verified
Catania, Italy

Trial locations

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Investigated drugs

Venetoclax
is a medication used in this study to help treat patients with a type of blood cancer called Acute Myeloid Leukemia (AML). It works by targeting and blocking a specific protein in cancer cells, which can help to stop the cancer cells from growing and multiplying.
Decitabine
is another medication used in combination with Venetoclax in this study. It is a type of chemotherapy that helps to slow or stop the growth of cancer cells. Decitabine works by affecting the DNA of the cancer cells, which can lead to their death.

What is already known about the treatment

Venetoclax
Venetoclax is taken orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating Acute Myeloid Leukemia (AML), particularly in elderly patients. The medication works by inhibiting a protein called BCL-2, which helps cancer cells survive. By blocking this protein, Venetoclax promotes the death of cancer cells. It is classified as a BCL-2 inhibitor and is being explored as part of a "chemo-free" treatment regimen.
Decitabine
Decitabine is administered through intravenous infusion. It is being investigated in clinical trials for its role in treating Acute Myeloid Leukemia (AML) in older patients. Decitabine works by incorporating into DNA and inhibiting DNA methylation, which can reactivate genes that suppress tumor growth. This medication is classified as a hypomethylating agent and is used in combination with Venetoclax to enhance treatment outcomes in AML.

Investigated diseases

Acute Myeloid Leukemia (AML) – This is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. AML can affect people of any age but is more common in older adults. The disease can vary in its specific genetic mutations, which can influence its behavior and progression. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen.