Second STOP After Pioglitazone Priming in CML Patients
ConditionChronic Myeloid Leukemia (CML)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVersailles Hospital
About this trial
Single-center study, prospective, phase II trial.
The study objectives are :
* To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation. * To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain \< MR4.5 with the combination PIO and TKI administered for at least 6 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CML in any phase. patient in MR4
Loss of MMR following a first or subsequent TKI discontinuation trial.
Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib
Age >18 years.
Disqualifiers
Known loss of CCyR by marrow cytogenetic or blood FISH for BCR-ABL1.
Loss of CHR.
Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment.
Prior allogeneic hematopoietic stem cell transplantation.
Trial design
Design model
Single group
Treatments tested in this trial
Pioglitazone + TKI
Drug
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: CML patients following molecular response lossExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame
Up to 24 months after inclusion2
Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.
Time frame
Up to 24 months after inclusionSponsors and contacts
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Source ClinicalTrials.gov