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Study of Pioglitazone and Avelumab Combined with Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients with Complete Cytogenetic Response

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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 Chronic Phase Chronic Myelogenous Leukemia (CP-CML), a type of blood cancer. The study evaluates two medications: Actos (containing pioglitazone) taken as tablets by mouth, and avelumab, which is given through intravenous infusion (delivered into a vein). These treatments will be used alongside standard cancer medications called tyrosine kinase inhibitors.

The purpose of this research is to find out if adding these new treatments to existing therapy can help more patients achieve a deeper level of response to treatment. The study will last for 12 months, during which patients will receive either Actos tablets up to 45 mg daily or avelumab infusions at doses calculated based on body weight, in addition to their regular cancer medication.

Throughout the study, doctors will monitor how well the treatment is working by measuring the levels of cancer markers in the blood. They will also track any side effects that patients may experience. The treatment schedule and doses will be determined by the study doctors based on each patient's individual needs and response to the medication.

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 eligibility confirmation
Your medical records will be reviewed to confirm you have chronic phase chronic myelogenous leukemia (CP-CML) and have been treated with specific medications (imatinib, nilotinib, dasatinib, or bosutinib) for more than 2 years
Basic health checks will be performed, including blood tests to verify your liver function and blood cell counts
A pregnancy test will be required for women who can become pregnant
Step 2
Treatment assignment
You will receive either:
Option 1: Actos (pioglitazone) 15 mg tablets taken by mouth
Option 2: Avelumab given through an intravenous infusion
Your current leukemia medication will continue throughout the study
Step 3
Regular monitoring
Your response to treatment will be monitored through regular blood tests
The main goal is to measure the levels of a marker called BCR-ABL1 in your blood
Blood tests will be conducted at regular intervals throughout the 12-month primary study period
Step 4
Long-term follow-up
Your progress will continue to be monitored for up to 48 months
Regular health assessments and blood tests will continue throughout this period
Any side effects will be recorded and monitored
Step 5
Study completion
The study will evaluate how well the treatment worked in reducing your BCR-ABL1 levels
Your long-term health status will be monitored
The total study duration may continue until December 2028

Who can join the trial?

16 criteria

Must be at least 18 years old
Liver function tests (ASAT and ALAT) must be no more than 2.5 times the normal limit
Blood bilirubin levels must be no more than 2.5 times the normal limit
Must use effective contraception if able to have children
Must have adequate blood cell counts (for avelumab treatment group): - Neutrophils (white blood cells) at least 1.5 × 109/L - Platelets at least 100 × 109/L - Hemoglobin at least 9 g/dL
Must have acceptable kidney function with creatinine clearance of at least 30 mL/min (for avelumab treatment group)
Women who can become pregnant must have a negative pregnancy test (for avelumab treatment group)
Must use highly effective contraception during the study and for 30 days after last avelumab treatment
Must sign informed consent form
Must have chronic phase CML with positive M BCR-ABL1 test
Must have been treated with imatinib, nilotinib, dasatinib, or bosutinib for more than 2 years total
Must not have changed between different cancer medications in the last 3 months
Must not have had dose changes in the last 3 months
Must have complete cytogenetic response or BCR-ABL1 levels of 1% or less
Must have detectable BCR-ABL1 levels above 0.0032%
Must have good physical performance status (ECOG grade 0 to 2, meaning able to care for self and up at least 50% of waking hours)

Who cannot join the trial?

15 criteria

Age below 18 or above 65 years old
Known allergy or sensitivity to any of the study medications
Pregnant or breastfeeding women
Patients with severe kidney problems (severe renal impairment)
Patients with severe liver problems (severe hepatic dysfunction)
Active or uncontrolled infections
Presence of other types of cancer
History of heart problems including heart failure, unstable angina, or recent heart attack
Participation in other clinical trials within the past 30 days
Mental conditions that could interfere with following study procedures
Uncontrolled diabetes mellitus (high blood sugar)
History of non-compliance with medical treatments
Life expectancy less than 6 months due to other medical conditions
Unable to provide informed consent
Substance abuse or alcoholism within the past year

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Verified sites

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

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Assistance Publique Hopitaux De Paris
Paris, France
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Centre Hospitalier De Versailles
Le Chesnay-Rocquencourt, France
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Centre Hospitalier Et Universitaire De Limoges
Limoges, France

Trial locations

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Investigated drugs

Imatinib
is a medication used to treat chronic myelogenous leukemia (CML). It belongs to a group of drugs called tyrosine kinase inhibitors that work by blocking certain proteins that signal cancer cells to multiply.
Nilotinib
is a cancer medication that works similarly to imatinib. It is used to treat chronic myelogenous leukemia by blocking specific proteins that cause cancer cells to grow and spread.
Dasatinib
is another medication in the tyrosine kinase inhibitor group used to treat chronic myelogenous leukemia. It works by stopping the growth of cancer cells by interfering with specific proteins that signal these cells to multiply.
Bosutinib
is also a tyrosine kinase inhibitor used in the treatment of chronic myelogenous leukemia. Like the other medications in this trial, it works by blocking certain proteins that promote cancer cell growth.

What is already known about the treatment

Imatinib
An oral medication used in the treatment of chronic myelogenous leukemia (CML), administered as tablets once daily. This tyrosine kinase inhibitor works by blocking specific proteins responsible for cancer cell growth, particularly targeting the BCR-ABL protein that drives CML progression. It is considered a first-line treatment for chronic phase CML and has revolutionized the management of this blood cancer since its introduction.
Nilotinib
A second-generation tyrosine kinase inhibitor taken orally as capsules, specifically designed for treating chronic myelogenous leukemia (CML). It functions by blocking the BCR-ABL protein more potently than imatinib and is often used when patients show resistance or intolerance to initial therapy. The medication is typically administered twice daily and requires careful monitoring of response.
Dasatinib
A potent oral tyrosine kinase inhibitor used in treating chronic myelogenous leukemia (CML), taken once daily in tablet form. It works by inhibiting multiple tyrosine kinases, including BCR-ABL, and is particularly effective in patients who have developed resistance to other treatments. This medication can penetrate the central nervous system better than other similar drugs in its class.
Bosutinib
An oral tyrosine kinase inhibitor administered as tablets once daily for the treatment of chronic myelogenous leukemia (CML). It specifically targets the BCR-ABL protein and Src family kinases, making it effective in patients who have shown resistance to other treatments. This medication represents a newer generation of targeted therapy for CML with a unique binding profile.

Investigated diseases

Chronic Myelogenous Leukemia (CML) - A type of blood cancer that begins in the bone marrow, causing the body to produce too many white blood cells. The disease typically develops slowly during its chronic phase, when the bone marrow and blood contain less than 10% immature white blood cells called blast cells. During this phase, patients may experience mild symptoms such as fatigue, weight loss, or enlarged spleen. The condition is characterized by the presence of an abnormal chromosome called the Philadelphia chromosome, which creates a faulty protein that leads to uncontrolled cell growth. The chronic phase is the initial, most manageable phase of CML, during which the disease progresses slowly and blood cells can still carry out their normal functions.