Study of Venetoclax and Azacitidine for Adults 18+ with Acute Myeloid Leukemia Not Eligible for Standard Therapy

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called acute myeloid leukemia (AML). The trial is testing a combination of two medications: Venetoclax and Azacitidine. Venetoclax is taken as a tablet, while Azacitidine is given as an injection. The study is designed for patients who are newly diagnosed with AML, are 18 years or older, and are not eligible for the usual intensive chemotherapy due to age or other health conditions.

The purpose of the study is to gather initial information on how effective the combination of Venetoclax and Azacitidine is for this group of patients. Participants in the study will receive Venetoclax tablets and Azacitidine injections over a period of up to six months. The study will monitor how well the treatment works and how the patients respond to it. The trial is open-label, meaning both the researchers and participants know which treatments are being administered.

Throughout the study, various aspects will be observed, such as the response of the leukemia to the treatment, the time it takes for the treatment to show effects, and the overall survival of the participants. The study will also look at the quality of life of the patients during the treatment period. This trial aims to provide valuable insights into the potential benefits of this treatment combination for patients with AML who have limited treatment options.

1 beginning of treatment

Upon joining the study, the treatment begins with the administration of two medications: venetoclax and azacitidine.

Venetoclax is taken orally in the form of a film-coated tablet called Venclyxto 100 mg. The dosage and frequency will be determined by the study team based on individual needs.

Azacitidine is administered as a subcutaneous injection, which means it is injected under the skin. The product used is called Vidaza 25 mg/ml powder for suspension for injection.

2 treatment cycle

The treatment is organized into cycles. Each cycle includes 5 days of azacitidine administration.

The study aims to evaluate the response to the treatment over a period of up to 6 cycles. The response is measured by the rate of complete remission (CR) or complete remission with incomplete blood count recovery (CRi).

3 monitoring and assessments

Throughout the trial, regular monitoring and assessments are conducted to evaluate the effectiveness and safety of the treatment.

These assessments may include blood tests, physical examinations, and questionnaires to measure quality of life.

4 end of treatment

The trial is expected to continue until December 1, 2024, unless the treatment is discontinued earlier due to specific reasons such as achieving the desired response or experiencing significant side effects.

The study team will provide guidance on the next steps after the trial concludes.

Who Can Join the Study?

Confirmed diagnosis of Acute Myeloid Leukemia (AML) by WHO criteria 2016 and not eligible for standard treatment due to age or other health conditions.
Age 18 years or older.
Expected to live for at least 12 more weeks.
Have good enough kidney and liver function.

Who Cannot Join the Study?

Patients who do not have acute myeloid leukemia cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Gemeinschaftspraxis Haematologie Onkologie	Dresden	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Kliniken Maria Hilf GmbH Moenchengladbach	Moenchengladbach	Germany
Rotkreuzklinikum Munchen gGmbH	Munich	Germany
Kiblzswypucoc Stgncfbf Ggka	Sindelfingen	Germany
Cnci Tktlc Kbjesida gryxe	Cottbus	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.03.2023

Trial locations

Investigated drugs:

Venetoclax is a medication used in this trial to help treat acute myelogenous leukemia, a type of blood cancer. 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 slow down the progression of the disease.

Azacitidine is another medication used in combination with Venetoclax in this trial. It is designed to help treat acute myelogenous leukemia by interfering with the growth of cancer cells. Azacitidine works by incorporating itself into the DNA of the cancer cells, which can disrupt their ability to grow and divide. This can help reduce the number of cancer cells in the body and improve the patient’s condition.

Investigated diseases:

Acute myeloid leukaemia

Acute myeloid leukemia – Acute myeloid leukemia 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. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression of the disease requires prompt medical attention to manage symptoms and complications.

Trial ID:

2022-501537-23-00

Protocol code:

VENAZA-5S

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Venetoclax and Azacitidine for Adults 18+ with Acute Myeloid Leukemia Not Eligible for Standard Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?