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
Qualifiers
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
Treatments tested in this trial
- Pioglitazone + TKI
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov