Trials / Unknown
UnknownNCT02889003
Second STOP After Pioglitazone Priming in CML Patients
Combination Study of Pioglitazone and Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia Patients After Failure of a First TKIs Discontinuation Attempt in Order to Prepare a New Stop
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- Sponsor
- Versailles Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pioglitazone + TKI |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2021-12-01
- Completion
- 2021-12-01
- First posted
- 2016-09-05
- Last updated
- 2018-03-22
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02889003. Inclusion in this directory is not an endorsement.