coiaward2010

PIO2STOP = Pioglitazone plus TKI to prepare for second stopping attempt [France]

Study title

Pioglitazone plus TKI to prepare for second stopping attempt (PIO2STOP) [France]

Scientific title

Combination study of pioglitazone and tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia patients after failure of a first TKI discontinuation attempt to in order to prepare a new stop

Indication and most important inclusion criteria

This study includes patients who:
- have chronic myeloid leukemia (CML) in any phase
- are at least 18 years old
- have been treated with imatinib, dasatinib, nilotinib or bosutinib before
- have discontinued tyrosine kinase inhibitor (TKI) treatment during a first stop trial and thereafter lost MMR
- have achieved deep molecular response (MR4.5)
- have adequate liver and kidney function

Short description of intervention

The purpose of this study is to evaluate whether the combination of pioglitazone with a tyrosine kinase inhibitor (TKI) is safe in patients who have lost major molecular response (MMR) after stopping a first TKI.

Study participants will be started on or continue with the same TKI and at the same dose as before discontinuation. They will also receive pioglitazone 30 mg once daily. After 2 months the pioglitazone dose will be increased to 45 mg once daily in patients who do not have any adverse events of grade 2 or worse.

Patients need to have achieved deep molecular response (MR4.5) before inclusion. They will receive pioglitazone and the TKI for 6 months in the study and will then have the option of stopping the combination treatment altogether. They will then be monitored for 2 years to see if they remain well without any treatment. Patients will be followed up for 5 years.

Type of study

Treatment discontinuation trial

Current status

Recruiting

Study sponsor

Hôpitaux de Versailles, Hôpital Mignot, France

Scientific lead / contact

Pr Philippe Rousselot
Centre Hospitalier de Versailles
France

Principal investigator

Pr Philippe Rousselot
Centre Hospitalier de Versailles
France

Additional information

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Study centers / principal investigators

France

Le Chesnay, 78157
Centre Hospitalier de Versailles
Hôpital André Mignot
Service de Médecine B Hématologie-Oncologie
Pr Philippe Rousselot

USA