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 study about?

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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CHU d’Estaing Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France
Hôpital Archet 2 Nice France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hôpital Avicenne Bobigny France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Edouard Herriot Lyon France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Institut Universitaire contre le Cancer Toulouse France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
22.02.2016

Trial locations

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.

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.

Trial ID:
2024-516328-32-00
Protocol code:
P13/12
Trial Phase:
Therapeutic exploratory (Phase II)

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