Study on Decitabine, Venetoclax, and Tretinoin for Patients with Acute Myeloid Leukemia Who Cannot Have Induction Chemotherapy

3 1 1

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 designed for patients who have been newly diagnosed with AML and are not eligible for standard induction chemotherapy, which is a common initial treatment for this disease. The study will explore the effects of a treatment combination that includes two medications, decitabine and venetoclax, along with either all-trans retinoic acid (ATRA) or a placebo. ATRA is a form of vitamin A that is sometimes used in cancer treatment.

The purpose of the study is to compare how well ATRA works compared to a placebo when added to the treatment with decitabine and venetoclax. Participants in the study will receive these treatments in the form of capsules taken by mouth. The study will last for a period of up to 60 days, during which the effects of the treatment on the patients’ overall survival will be observed. The trial aims to provide valuable information on whether adding ATRA to the treatment can improve outcomes for patients with AML.

Throughout the study, researchers will monitor various aspects of the patients’ health, including their response to the treatment and their quality of life. This will help determine the effectiveness of the treatment combination and its impact on the patients’ well-being. The study is expected to continue until September 2027, providing a comprehensive evaluation of the treatment’s potential benefits for individuals with acute myeloid leukemia.

1 joining the trial

Upon joining the trial, you will be asked to provide written informed consent. This means you agree to participate after understanding the trial’s purpose, procedures, and potential risks and benefits.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes checking your age, medical history, and current health status. Your white blood cell count will be measured, and other criteria will be evaluated to ensure you meet the trial requirements.

3 randomization

You will be randomly assigned to one of two groups. One group will receive the standard treatment with decitabine and venetoclax combined with all-trans retinoic acid (ATRA), while the other group will receive the standard treatment with a placebo.

4 treatment phase

During the treatment phase, you will take the medications orally. Decitabine and venetoclax are part of the standard treatment. If you are in the ATRA group, you will also take all-trans retinoic acid. The exact dosage and frequency will be provided by the medical team, and you will be monitored regularly to assess your response to the treatment.

5 regular monitoring

Throughout the trial, regular monitoring will occur. This includes blood tests, health assessments, and possibly other procedures to track your progress and any side effects. The goal is to ensure your safety and evaluate the treatment’s effectiveness.

6 end of treatment

At the end of the treatment period, a final assessment will be conducted. This will involve evaluating your overall health, the effectiveness of the treatment, and any changes in your condition.

7 follow-up

After completing the treatment, follow-up visits may be scheduled to continue monitoring your health and gather long-term data on the treatment’s effects.

Who Can Join the Study?

Age must be 18 years or older.
Must have newly diagnosed acute myeloid leukemia (AML) and not have received any treatment for it before.
Must have an ECOG performance status of 2 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities, where 0 means fully active and 5 means dead.
White blood cell count must be less than 25 billion per liter. Medications like hydroxyurea or Ara-C can be used to meet this requirement.
Patients who are not expected to benefit from standard induction therapy or for whom standard induction chemotherapy is not feasible. This includes:
- Age 75 years or older
- ECOG performance status of 1 or more
- HCT-CI score of 3 or more. This is a score that predicts the risk of complications after a stem cell transplant.
- Adverse genetic factors
- Patient declines standard aggressive chemotherapy
- Lack of a social support system
Must have a projected life expectancy of at least 8 weeks.
Must provide written informed consent according to international guidelines and local laws. This means you agree to participate in the study after being informed about all aspects of the trial.
Must have the ability to understand the nature, significance, and consequences of the trial and the trial-related procedures and to comply with them.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with acute myeloid leukemia (AML) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Jena KöR	Jena	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Pius-Hospital Oldenburg	Oldenburg In Holstein	Germany
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Barmherzige Brueder Trier gGmbH	Trier	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Caritas Traegergesellschaft Saarbruecken mbH (CTS)	Saarbrücken	Germany
Maerkische Kliniken GmbH	Luedenscheid	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Ortenau Klinikum	Offenburg	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Myzyweqeqjybigaxauysmvelvo Hfepqnuzwulwfvjm	Halle (Saale)	Germany
Uqdzwbkcuscdahzjapogf Aknbqjxo	Augsburg	Germany
Azpxaingxxjflkpwnbomikt ghyzm	Bochum	Germany
Sypuaymwqtxcurfttxiwv gmkvh	Eschweiler	Germany
Kxdnuyobkgfp Karobmwwpne Hjiry Sr Jwptlw Hqaaittm	Hagen	Germany
Kvzjhadtciqr Kixyzkwmzirmurdtymiqy gobjal Wggernyuxgxctzesmkdhaw Ghzm	Goch	Germany
Ucjtjpibppgctxfscukzo Divijgyjatp Awc	Duesseldorf	Germany
Upxxeuiajwlekzhemiluf Mkkfwpdj Aap	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	17.10.2022

Trial locations

Investigated drugs:

Decitabine is a medication used in the treatment of certain types of blood cancers, including acute myeloid leukemia (AML). It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. In this trial, decitabine is part of the main treatment plan for patients who cannot undergo standard chemotherapy.

Venetoclax is another medication used to treat blood cancers like AML. It helps to kill cancer cells by targeting a specific protein that allows these cells to survive. By blocking this protein, venetoclax helps to reduce the number of cancer cells in the body. In this trial, it is used alongside decitabine as part of the main treatment.

All-trans retinoic acid (ATRA) is a form of vitamin A that is used in the treatment of certain types of leukemia. It helps cancer cells to mature and die more normally. In this trial, ATRA is being tested to see if adding it to the main treatment with decitabine and venetoclax can improve patient outcomes, specifically overall survival.

Investigated diseases:

Acute myeloid leukaemia

Acute Myeloid Leukemia (AML) – 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 growth of abnormal cells can lead to a decrease in red blood cells and platelets, further complicating the condition. AML requires prompt medical attention due to its fast progression.

Trial ID:

2023-507461-26-00

Protocol code:

P001516

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Decitabine, Venetoclax, and Tretinoin for Patients with Acute Myeloid Leukemia Who Cannot Have Induction Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?