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New treatment option for Chronic Myeloid Leukemia (CML)
Official title Second STOP After Pioglitazone Priming in CML Patients
ClinicalTrials.gov ID: NCT02889003
What this study is testing
What is Pioglitazone + TKI?
Pioglitazone + TKI is an investigational medicine, being studied as a potential treatment for chronic myeloid leukemia (cml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Serum bilirubin \<1.5 x upper limit of normal values.
You likely can't join if
- 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.
- Patient requiring anti-diabetic medications to manage hyperglycemia.
- Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia...
See the full eligibility criteria
- 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.
- Serum bilirubin \<1.5 x upper limit of normal values.
- AST (SGOT)/ALT (SGPT) \<2.5x upper limit of normal values.
- Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing...
- Males must agree to abstain from sexual activity or agree to utilize a medically-approved contraception method during and for 3 months after the treatment period.
- Signed informed consent.
- Be able and willing to comply with study visits and procedures
- 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.
- Patient requiring anti-diabetic medications to manage hyperglycemia.
- Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment.
- Hepatic insufficiency
- History of bladder cancer.
- Diagnosed hematuria.
- Known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria)
- Known history of macular edema.
- Known history of ABL1-domain mutation associated with resistance to the discontinued TKI.
- Known allergy to PIO.
- Pregnant or breastfeeding.
- Use of TZD within 28 days prior to enrollment.
- Significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug.
- Uncontrolled peripheral edema (2+ or more) of any etiology
The study team makes the final eligibility decision.
Where it's taking place
- Le Chesnay, France
- Le Kremlin-Bicêtre, France
- Lyon, France
- Nantes, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Chesnay, France; Le Kremlin-Bicêtre, France; Lyon, France; Nantes, France; Rennes, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.