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Study of Venetoclax and Low Dose Cytarabine for Untreated Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

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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 study is investigating the effects of a medication called Venetoclax, which is taken as a film-coated tablet, in combination with another medication called Cytarabine, which is given as a low-dose injection. The purpose of the study is to see if this combination can help improve the overall survival of patients who have not received treatment before and are not eligible for intensive chemotherapy.

Participants in the study will be randomly assigned to receive either the combination of Venetoclax and low-dose Cytarabine or low-dose Cytarabine with a placebo. The study will be conducted over a period of time, and participants will be monitored to assess their response to the treatment. The study aims to provide valuable information on whether the combination of these medications can offer better outcomes for patients with Acute Myeloid Leukemia.

Throughout the study, participants will receive regular check-ups and assessments to monitor their health and the effects of the treatment. The study will help researchers understand if the combination of Venetoclax and low-dose Cytarabine can be a more effective treatment option for patients with Acute Myeloid Leukemia who are unable to undergo intensive chemotherapy.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to age, health status, and medical history.

A consent form is signed to acknowledge understanding of the study’s procedures and objectives.

2 initial assessment

An initial assessment is conducted to evaluate overall health and establish baseline measurements.

This includes blood tests, imaging, and other necessary evaluations to confirm the diagnosis of acute myeloid leukemia.

3 treatment phase

The treatment involves the administration of venetoclax and cytarabine.

Venetoclax is taken orally in the form of film-coated tablets.

Cytarabine is administered as a subcutaneous injection.

The dosage and frequency are determined by the study protocol and adjusted based on individual response and tolerance.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment and any side effects.

This includes routine blood tests, physical examinations, and patient-reported outcomes.

Adjustments to the treatment plan may be made based on these assessments.

5 end of treatment

The treatment phase concludes as per the study’s timeline or upon achieving the desired outcomes.

A final assessment is conducted to evaluate the overall response to the treatment.

6 post-study follow-up

After the treatment phase, follow-up visits are scheduled to monitor long-term health and any late effects of the treatment.

These visits help in understanding the overall survival and quality of life post-treatment.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of Acute Myeloid Leukemia (AML), which is a type of blood cancer.
  • The patient must be unable to undergo intensive chemotherapy and be either:
    • 75 years of age or older, or
    • Between 18 to 74 years of age and meet at least one of the following conditions:
      • Have an ECOG Performance status of 2 to 3, which is a scale used to assess how a disease affects a patient’s daily living abilities.
      • Have a history of heart problems like Congestive Heart Failure (CHF) or a heart ejection fraction of 50% or less, or stable chest pain.
      • Have lung function tests showing DLCO or FEV1 of 65% or less, which measure how well the lungs work.
      • Have a creatinine clearance between 30 to less than 45 mL/min, indicating kidney function.
      • Have moderate liver issues with bilirubin levels between 1.5 to 3 times the normal limit.
      • Have other health issues that make intensive chemotherapy unsuitable, as judged by a doctor and approved by the study team.
  • The patient must have an ECOG Performance status of 0 to 2 if they are 75 years or older, or 0 to 3 if they are between 18 to 74 years old.
  • The patient must have a life expectancy of at least 12 weeks.
  • The patient must have adequate kidney function, shown by a creatinine clearance of 30 mL/min or more.
  • The patient must have adequate liver function, shown by:
    • AST and ALT levels 3 times or less than the normal limit.
    • Bilirubin levels 1.5 times or less than the normal limit, or 3 times or less if under 75 years old.
  • Female patients must be either:
    • Postmenopausal, meaning no menstrual periods for 12 months or more without another medical reason, or
    • Surgically sterile, or
    • Using a specified method of birth control from the start of the study until 180 days after the last dose of the study drug.
  • Male patients who are sexually active must agree to use contraception from the start of the study until 180 days after the last dose of the study drug and must not donate sperm during this time.
  • Females of childbearing potential must have a negative pregnancy test before starting the study and before dosing if more than 7 days have passed since the last test.
  • The patient must voluntarily sign and date an informed consent form approved by an ethics committee before any study procedures begin.

Who Cannot Join the Study?

  • Patients who have previously received treatment for Acute Myeloid Leukemia cannot participate. Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who are not able to take the study medications as required will be excluded.
  • Patients with other serious health conditions that might interfere with the study will not be allowed to join.
  • Pregnant or breastfeeding women cannot participate in the study.
  • Patients who are participating in another clinical trial at the same time will be excluded.
  • Patients who have had an allergic reaction to similar medications in the past will not be eligible.
  • Patients who are unable to follow the study procedures or attend the required visits will be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Clinique Victor Hugo Le Mans France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
04.09.2014

Trial locations

Investigated drugs:

Venetoclax is a medication used in this study to see if it can help improve survival in patients with acute myeloid leukemia (AML) who have not received treatment before and are not eligible for intensive chemotherapy. It is being tested to see if it works better when given together with another medication called low dose cytarabine.

Low Dose Cytarabine is a chemotherapy drug used in this study as a treatment for acute myeloid leukemia (AML). It is given in a lower dose to patients who cannot undergo intensive chemotherapy. The study is testing whether adding venetoclax to this treatment can improve patient outcomes.

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect the blood. 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. Symptoms may include fatigue, fever, frequent infections, and easy bruising or bleeding. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. AML is more common in adults and can develop suddenly, requiring prompt medical attention. The progression of the disease can vary, but it typically involves a rapid increase in the number of immature blood cells.

Trial ID:
2024-513630-37-00
Protocol code:
M16-043
NCT ID:
NCT03069352
Trial Phase:
Therapeutic confirmatory (Phase III)

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