Second STOP After Pioglitazone Priming in CML Patients
Recruiting
Phase 2
Interventional Study
Chronic Myeloid Leukemia (CML)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 26 (estimated)
- Sponsor
- Versailles Hospital · Other
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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 combi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. CML in any phase. patient in MR4
2. Loss of MMR following a first or subsequent TKI discontinuation trial.
3. Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib
4. Age \>18 years.
5. Serum bilirubin \<1.5 x upper limit of normal values.
6. AST (SGOT)/ALT …
Contacts