Study comparing venetoclax with intensive chemotherapy (daunorubicin, cytarabine, gemtuzumab ozogamicin) in patients with favorable risk acute myeloid leukemia

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What is this study about?

This study focuses on patients with Acute Myeloid Leukaemia, a type of blood cancer that affects the bone marrow and blood cells. The study aims to compare two different treatment approaches for this disease. One approach uses venetoclax (also known as ABT-199) combined with low-dose cytarabine, while the other approach uses intensive chemotherapy that includes daunorubicin hydrochloride and gemtuzumab ozogamicin.

The first treatment option involves taking venetoclax tablets by mouth along with cytarabine given through injections or infusions. The second treatment option consists of intensive chemotherapy medications given through intravenous infusions. The study will monitor how well each treatment works in preventing the return of the disease and helping patients achieve remission, which means there are no detectable cancer cells.

During the study, patients will receive treatment for up to 24 months. Throughout this time, doctors will regularly check the patient’s health status, perform blood tests, and monitor for any side effects. The study will track how long patients remain free from disease progression and measure their overall survival time. Quality of life and general health status will also be assessed at various points during the study period.

1 Initial treatment assignment

After joining the study, you will be assigned to receive either venetoclax with low-dose cytarabine or intensive chemotherapy

Your treatment assignment will be based on your specific molecular profile

2 Treatment cycles

You will receive two cycles of the assigned treatment

The medications may include:

Venetoclax: tablets taken by mouth

Cytarabine: given through an IV (intravenous) line or as an injection under the skin

Daunorubicin: given through an IV line

Gemtuzumab ozogamicin: given through an IV line

3 Response evaluation

After two treatment cycles, your response to therapy will be evaluated

This evaluation includes checking if the leukemia cells have decreased or disappeared from your blood and bone marrow

4 Follow-up assessments

Regular check-ups will occur at months 3, 6, 12, 18, and 24

These visits will include:

– Blood tests to monitor your condition

– Assessment of your general health and ability to perform daily activities

– Quality of life evaluations

At months 12 and 24, a comprehensive health assessment for older adults will be performed

5 Monitoring period

Your health status will be monitored for up to 24 months

The study will track:

– How well the treatment is working

– Any side effects you may experience

– Your overall survival and quality of life

– The amount of hospital care and medical support you need

Who Can Join the Study?

  • Must be diagnosed with CD33 positive Acute Myeloid Leukaemia (a type of blood cancer)
  • Must be 55 years or older
  • Must have specific genetic markers: NPM1 mutation and be negative for FLT3 ITD (patients with FLT3 TKD mutation can participate)
  • Must have an ECOG performance status of 0-2 (a scale measuring daily living abilities, where 0 means fully active and 2 means able to do light activities)
  • Must have kidney function tests showing serum creatinine no more than 1.5 times the normal upper limit
  • Must have liver function tests (ALT and AST) no more than 2.5 times the normal upper limit, and bilirubin no more than 2 times the normal upper limit
  • Must be able to provide written informed consent
  • Must be considered physically fit enough to receive intensive chemotherapy with anthracyclines (strong cancer medications) as determined by their doctor

Who Cannot Join the Study?

  • Prior chemotherapy or targeted therapy for Acute Myeloid Leukaemia (AML) except for emergency treatment
  • Active central nervous system involvement with AML (cancer cells present in brain or spinal cord)
  • Severe heart conditions including:
    • Uncontrolled heart failure
    • Recent heart attack (within last 6 months)
    • Unstable heart rhythm problems
  • Severe liver problems (liver function tests more than 3 times above normal limits)
  • Severe kidney problems (requiring dialysis)
  • Active uncontrolled infections
  • Other types of cancer requiring treatment
  • Pregnancy or breastfeeding
  • Unable to take oral medications
  • Known allergies to study medications
  • Mental conditions that would interfere with study compliance
  • Life expectancy less than 3 months due to other medical conditions
  • Participation in other clinical trials within last 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Ansubn Uvizhzckky Hnrgqypx Aarhus Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
31.01.2025

Trial locations

Venetoclax is a medication used to treat acute myeloid leukemia (AML). It works by blocking a protein that helps cancer cells survive. This medication is taken orally and helps to kill cancer cells while sparing healthy cells.

Cytarabine is a chemotherapy medication used to treat blood cancers, including acute myeloid leukemia. It works by interfering with DNA synthesis in cancer cells, which prevents them from growing and dividing. This medication is typically given through an intravenous infusion.

Intensive Chemotherapy refers to a strong combination of cancer-fighting medications given at high doses to treat acute myeloid leukemia. This treatment approach is typically administered in a hospital setting and may require extended hospital stays due to its intensity and side effects.

Investigated diseases:

Acute Myeloid Leukemia – A type of blood and bone marrow cancer that progresses rapidly. The disease begins in the bone marrow, where abnormal white blood cells multiply uncontrollably, interfering with the production of normal blood cells. These abnormal cells build up in the bone marrow and blood, reducing the body’s ability to produce healthy blood cells. The condition typically develops quickly, over days or weeks, affecting the production of red blood cells, platelets, and normal white blood cells. It most commonly occurs in older adults, though it can affect people of any age.

Trial ID:
2024-516116-19-00
Protocol code:
RG_19-282
Trial Phase:
Therapeutic exploratory (Phase II)

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