Study of Pioglitazone and Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia Patients After Stopping Treatment Attempts

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What is this study about?

This clinical trial is focused on studying Chronic Myeloid Leukemia (CML), a type of cancer that affects the blood and bone marrow. The study involves the use of a medication called Pioglitazone, which is taken in the form of tablets, and a group of drugs known as Tyrosine Kinase Inhibitors (TKIs). These TKIs include medications like imatinib, dasatinib, nilotinib, and bosutinib. The purpose of the study is to explore the safety and behavior of the combination of Pioglitazone and TKIs in patients with CML who have experienced a return of the disease after stopping TKIs, with the aim of preparing for another attempt to stop the medication.

Participants in the study will take Pioglitazone and TKIs together, and their health will be monitored over a period of time. The study will look at how well patients do without losing a specific response to treatment, known as MMR (Major Molecular Response), over a 12-month period after stopping the combination of Pioglitazone and TKIs. This will involve regular blood tests to check for the presence of a specific marker called BCR-ABL1, which is associated with CML. The study will also keep track of any side effects that participants might experience while taking the combination of medications.

The trial aims to provide valuable information on whether the combination of Pioglitazone and TKIs can help patients maintain their health after stopping TKIs, potentially leading to new treatment strategies for those with CML. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 enrollment and consent

Upon joining the study, you will be required to provide a signed informed consent. This document confirms your understanding of the study and your willingness to participate.

You will undergo a series of initial assessments to ensure you meet the study’s eligibility criteria. These assessments include verifying your medical history and current health status.

2 initial treatment phase

You will begin taking Actos 30 mg tablets, which contain the active substance pioglitazone. This medication is taken orally in the form of a tablet.

The dosage and frequency of the medication will be determined by the study protocol and your healthcare provider. It is important to follow the prescribed schedule for the duration of the study.

3 combination treatment

In addition to pioglitazone, you will receive a tyrosine kinase inhibitor (TKI). This is a type of medication used to treat chronic myeloid leukemia.

The combination of pioglitazone and TKI aims to assess safety and effectiveness in maintaining molecular response in patients.

4 monitoring and assessments

Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. These visits will include blood tests and other necessary assessments.

Blood tests will be conducted monthly for the first six months, then quarterly for the next six months, and bi-annually thereafter, to evaluate the levels of specific markers in your blood.

5 discontinuation phase

If eligible, you may undergo a discontinuation phase where the medications are gradually stopped. This phase aims to assess your ability to maintain a molecular response without the treatment.

Your health and response to the discontinuation will be closely monitored to ensure safety and effectiveness.

6 follow-up

After the treatment period, you will continue to be monitored for a specified duration to assess long-term outcomes and any potential side effects.

It is important to attend all scheduled follow-up visits and report any changes in your health to the study team.

Who Can Join the Study?

Have Chronic Myelogenous Leukemia (CML) in any phase and be in MR4.5 (a specific level of response to treatment).
Be able and willing to attend study visits and follow study procedures.
Have experienced a loss of MMR (a specific level of response to treatment) after stopping a TKI (a type of medication used to treat CML).
Have been treated with imatinib, dasatinib, nilotinib, or bosutinib for more than 2 years since the last time you stopped treatment.
Be older than 18 years.
Have a serum bilirubin level less than 1.5 times the upper limit of normal values (bilirubin is a substance in the blood that can indicate liver function).
Have AST (SGOT) and ALT (SGPT) levels less than 2.5 times the upper limit of normal values (these are enzymes that help assess liver function).
If you are a female who can have children, you must agree to avoid sexual activity or use a medically approved birth control method during and for 3 months after the treatment period. You must also have a negative urine pregnancy test at the time of enrollment. Acceptable birth control methods include oral contraceptives, intrauterine devices, transdermal/implanted or injected contraceptives, and abstinence.
If you are male, you must agree to avoid sexual activity or use a medically approved birth control method during and for 3 months after the treatment period.
Provide signed informed consent, which means you agree to participate in the study after being informed about it.

Who Cannot Join the Study?

Patients who have not been diagnosed with Chronic Phase Chronic Myelogenous Leukemia (CML) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.
Patients who have not experienced a loss of MMR (Major Molecular Response) after stopping a TKI (Tyrosine Kinase Inhibitor) cannot participate.
Patients who are not eligible to discontinue TKI treatment cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Lyon Sud	Pierre Benite	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	22.12.2016

Trial locations

Investigated drugs:

Pioglitazone

Pioglitazone is a medication that is often used to help control blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being used in combination with other medications to help treat patients with Chronic Myeloid Leukemia (CML) who have experienced a return of their disease after stopping another type of treatment. The goal is to see if Pioglitazone can help these patients maintain their health and prevent the disease from coming back.

Tyrosine Kinase Inhibitors (TKIs) are a group of medications that work by blocking certain proteins that help cancer cells grow. In this trial, TKIs are being used alongside Pioglitazone to treat patients with Chronic Myeloid Leukemia (CML). The aim is to see if this combination can help patients who have had a return of their disease after stopping TKI treatment, and to help them stay healthy without the disease coming back.

Chronic Phase Chronic Myelogenous Leukemia – Chronic Phase Chronic Myelogenous Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as myeloid cells. In the chronic phase, the disease progresses slowly, and patients may not experience significant symptoms initially. Over time, the accumulation of these cells can interfere with normal blood cell production, leading to symptoms such as fatigue, weight loss, and an increased risk of infections. As the disease progresses, it can transition to more aggressive phases if not managed. The chronic phase is typically the initial stage of the disease, where it remains stable for a period before potentially advancing.

Trial ID:

2024-515460-31-00

Protocol code:

PIO2STOP_P16/05

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pioglitazone and Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia Patients After Stopping Treatment Attempts

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?