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Study of venetoclax and mercaptopurine combination treatment for patients with relapsed or treatment-resistant acute myeloid leukemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating patients with Acute Myeloid Leukemia (AML) that has come back after previous treatment or did not respond to initial treatment. AML is a type of blood cancer where abnormal white blood cells grow rapidly in the bone marrow, interfering with normal blood cell production.

The study will test a combination of two medications: venetoclax (also known as ABT-199) and mercaptopurine (also known as 6-MP). Venetoclax works by blocking a protein that helps cancer cells survive, while mercaptopurine interferes with cancer cell growth. Both medications are taken by mouth. This is the first time these two medications are being tested together to see if they work better in combination for treating AML.

The purpose of this study is to determine if this new combination treatment is effective for patients whose AML has either returned after previous treatment or did not respond to standard chemotherapy. The study will monitor how patients respond to the treatment and check for any side effects that may occur during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Your white blood cell count must be below 25x10^9/µL before starting treatment. If needed, you may receive medication to lower this count.
A waiting period of at least 24 hours after the last dose of cell-count lowering medication is required before starting the main treatment.
Step 2
Main treatment phase
You will receive two oral medications: venetoclax and mercaptopurine.
Both medications are taken by mouth according to the prescribed schedule.
Regular monitoring will occur throughout the treatment period to check your response to the medications.
Step 3
Response monitoring
Your response to treatment will be evaluated through regular blood tests and bone marrow examinations.
The following responses will be monitored:
- Complete remission: less than 5% abnormal cells in bone marrow, normal blood cell counts, and no need for transfusions
- Incomplete remission: improvement in bone marrow but blood counts not fully recovered
- Partial response: at least 50% reduction in abnormal cells
Step 4
Safety monitoring
Regular medical check-ups will assess your body's response to the treatment.
If you have reduced kidney function (filtration rate between 15-30 mL/min), additional close monitoring will be required.
Your doctor will monitor for potential side effects throughout the treatment period.
Step 5
Treatment duration
The study continues until February 2026.
The duration of your individual treatment will depend on your response and overall health status.

Who can join the trial?

10 criteria

Must be at least 18 years old
Must have a diagnosis of acute myeloid leukemia (AML) that has either:
- Come back after previous treatment (relapsed), or
- Not responded to previous treatment (refractory)
- Must have previously received at least:
  - One course of intensive chemotherapy, or
  - Four courses of hypomethylating agents (drugs that affect DNA)
  - Must have a WHO performance status of 0-3 (a measure of general wellbeing and ability to carry out daily activities)
  - Must not have previously been resistant to treatment with venetoclax (if previously treated with venetoclax, discussion with study doctor required)
  - Must have a white blood cell count below 25x10⁹/µL before starting treatment
  - Can participate with severe kidney problems (if benefits outweigh risks) but will need extra monitoring
  - Cannot have a specific subtype of AML called acute promyelocytic leukemia (M3)

Who cannot join the trial?

15 criteria

Active central nervous system leukemia (cancer cells present in brain or spinal cord)
Prior treatment with venetoclax within 30 days before starting the study
Severe liver problems (as shown by liver function tests)
Severe kidney problems (as shown by kidney function tests)
Uncontrolled active infection requiring intravenous antibiotics
Pregnant or breastfeeding women
Unable to swallow oral medications
Active second cancer requiring treatment
Serious heart conditions or uncontrolled heart disease
Known allergic reactions to the study medications
Participation in another clinical trial within 30 days
Mental conditions that could interfere with following study procedures
Life expectancy less than 3 months
HIV positive patients with detectable viral load
Active hepatitis B or C infection

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Verified sites

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Algemeen Ziekenhuis Delta
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Roeselare, Belgium
University Of Antwerp
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Edegem, Belgium

Trial locations

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Investigated drugs

Venetoclax (also known as ABT-199) is a medication used to treat blood cancers. It works by blocking a protein called BCL-2, which helps cancer cells survive. This medication is taken orally and helps promote cancer cell death. 6-Mercaptopurine (also called mercaptopurine) is a chemotherapy medication that belongs to a group called purine analogues. It works by interfering with cancer cell DNA, which prevents the cancer cells from growing and dividing. This medication is taken by mouth and has been used for many years to treat various blood cancers. This trial studies these two medications used together as a new combination treatment for patients with acute myeloid leukemia that has either come back after treatment or hasn't responded well to previous treatments.

What is already known about the treatment

Venetoclax
An oral medication used in the treatment of acute myeloid leukemia (AML), particularly in relapsed or refractory cases. This targeted therapy works by blocking the BCL-2 protein, which helps cancer cells survive, thereby promoting cancer cell death through a process called apoptosis. Venetoclax belongs to the class of medications known as BCL-2 inhibitors and is typically administered as tablets taken daily.
6-Mercaptopurine
An oral chemotherapy medication belonging to the purine analog class of drugs, used in the treatment of various blood cancers including acute myeloid leukemia. This medication works by interfering with DNA synthesis in cancer cells, preventing them from dividing and multiplying. It is taken by mouth in tablet form and is being studied in combination with venetoclax as a potential treatment option for patients with relapsed or refractory acute myeloid leukemia.

Investigated diseases

Acute Myeloid Leukemia - A blood and bone marrow cancer that affects the production of normal blood cells. In this condition, immature blood cells called myeloid cells develop abnormally and accumulate in the bone marrow. These abnormal cells interfere with the production of normal blood cells, leading to a decrease in healthy red blood cells, white blood cells, and platelets. The disease typically develops rapidly, with symptoms such as fatigue, frequent infections, and easy bruising or bleeding. AML can occur at any age but becomes more common in older adults.