Not recruitingRare disease

Study of Venetoclax in Chronic Myeloid Leukemia Patients After Stopping Tyrosine Kinase Inhibitor Treatment

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on patients with Chronic Myeloid Leukemia (CML), a type of blood cancer. The research examines the effectiveness of a medication called venetoclax in patients who have previously been treated with another type of cancer medication called tyrosine kinase inhibitors (TKIs) and achieved a deep remission of their disease.

The purpose of this research is to evaluate how well venetoclax works in targeting remaining cancer cells in patients who stop their TKI therapy. The medication venetoclax, also known as ABT-199, is taken by mouth once daily at a dose of 400 mg. The treatment period lasts for up to 12 months.

During the study, researchers will monitor how the medication affects the remaining cancer cells in the bone marrow. The study focuses on patients whose cancer has responded well to previous treatment, showing very low levels of cancer cells in their body. This is measured through special laboratory tests that look for specific genetic markers associated with CML.

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 phase
Your treatment begins with stopping the current tyrosine kinase inhibitor (TKI) therapy after achieving deep molecular remission.
Deep molecular remission means that the level of cancer cells in your body has decreased significantly.
The treatment requires at least 3 years of prior TKI therapy before starting this trial.
Step 2
Starting venetoclax treatment
You will receive venetoclax tablets at a dose of 400 mg daily.
The medication should be taken orally.
Regular blood tests will monitor your potassium, calcium, and magnesium levels.
Your kidney and liver function will be regularly checked through blood tests.
Step 3
Monitoring phase
Your cancer levels will be monitored through specialized blood tests measuring BCR::ABL1 levels.
Bone marrow samples will be taken to measure the number of cancer stem cells.
Regular health checks will include monitoring of liver function, kidney function, and blood values.
Step 4
Safety measures
If you are of childbearing age, regular pregnancy tests will be conducted.
You must use effective contraception methods during the treatment period.
Your overall health status will be regularly assessed.
Step 5
Study duration
The study continues until June 30, 2025.
Your participation duration may vary depending on when you join the study.

Who can join the trial?

15 criteria

Must be at least 18 years old
Diagnosed with chronic phase CML (a type of blood cancer) confirmed by genetic testing
Have either a Philadelphia chromosome or be positive for BCR::ABL1 in genetic testing
Have specific genetic markers called b2a2 and/or b3a2 BCR::ABL1 transcripts
Must have stored DNA samples from before starting treatment
Have achieved and maintained a deep level of remission (MR4 or better) confirmed three times in the past 13 months by certified laboratory
Must have been on TKI therapy (specific cancer medication) for at least 3 years
Can participate even if previous attempt to stop TKI treatment was unsuccessful, if deep remission was achieved again
Have good general health status (WHO performance status 0-2)
Have adequate liver function (specific blood test results within acceptable ranges)
Have adequate kidney function (creatinine clearance ≥ 30 mL/min)
Have normal or corrected levels of potassium, calcium, and magnesium in blood
Women who can become pregnant must use effective contraception methods, including both hormonal and barrier methods
Women who can become pregnant must have a negative pregnancy test
Must be willing and able to provide informed consent

Who cannot join the trial?

11 criteria

Patients younger than 18 years old cannot participate in the study
Patients who have not previously used BCR::ABL1 tyrosine kinase inhibitor therapy (TKI) - a type of targeted cancer treatment
Patients who have not achieved deep molecular remission (a state where the number of cancer cells has been significantly reduced to a very low level)
Patients who are still actively taking TKI therapy
Patients who have any serious medical conditions that could interfere with the study treatment
Patients who are currently participating in other clinical trials
Patients who have known allergies or hypersensitivity to venetoclax (the study medication) or its components
Pregnant or breastfeeding women
Patients who are unable to take oral medications
Patients who have significant liver or kidney problems
Patients who cannot follow or comply with the study protocol

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Universitaetsklinikum Aachen AöR
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Aachen, Germany
University Hospital Jena KöR
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Jena, Germany

Trial locations

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Investigated drugs

Venetoclax
is a medication that helps treat certain types of blood cancers. It works by blocking a protein that helps cancer cells survive. In this trial, it is being studied in patients with chronic myeloid leukemia (CML) who have previously responded well to other treatments.
Tyrosine Kinase Inhibitors (TKIs)
are a class of medications that block specific proteins involved in cancer growth. These medications are commonly used as the standard treatment for CML patients. In this trial, patients who have achieved good results with TKIs will discontinue them before starting venetoclax.

Venetoclax

What is already known about the treatment

Venetoclax - An oral medication that belongs to the class of BCL-2 inhibitors, primarily used in the treatment of blood cancers including Chronic Myeloid Leukemia (CML). The drug works by blocking the BCL-2 protein, which helps cancer cells survive, thereby promoting cancer cell death through a process called apoptosis. Venetoclax is administered as tablets taken once daily, and in this specific trial, it is being studied at a dose of 400 mg daily in patients who have previously achieved deep molecular remission with tyrosine kinase inhibitor (TKI) therapy. This medication represents a newer approach to treating persistent leukemia stem cells that may remain after conventional TKI therapy.

Investigated diseases

Chronic Myeloid Leukemia - A type of blood cancer that begins in the bone marrow when certain blood cells develop abnormally. The disease develops when a genetic change occurs in the blood-forming cells of the bone marrow, creating an abnormal gene called BCR-ABL. This condition causes the bone marrow to produce too many white blood cells that don't mature properly. The disease typically progresses slowly in its early phase, during which patients may experience fatigue, weight loss, and enlarged spleen. Over time, immature white blood cells begin to accumulate in the bone marrow and blood. The disease can progress through different phases, from chronic to more advanced stages.