Clinical trial · Interventional
Pioglitazone and Tyrosine Kinase Inhibitor in Treating Patients With Relapsed Chronic Myeloid Leukemia
Combination of Pioglitazone and Tyrosine Kinase Inhibitor (TKI) in Relapsed Chronic Myeloid Leukemia Following a First TKI Discontinuation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well pioglitazone hydrochloride and tyrosine kinase inhibitor (TKI) therapy works in treating patients with chronic myeloid leukemia (CML) that has come back after a period of improvement (relapsed) after a first TKI discontinuation. TKI may stop the growth of cancer cells by blocking certain enzymes need for cell growth. Although TKI therapies are effective against CML, there are residual cancer cells called leukemia stem cells that are able to hide from TKIs. Pioglitazone is a drug approved by the Food and Drug Administration to treat diabetes and has been shown in laboratory studies to increase CML stem cell death when given together with TKI therapy. Giving pioglitazone with TKI therapy may be effective in treating patients with CML.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pioglitazone | Drug | — | UNRESOLVED |
| Tyrosine Kinase Inhibitor (TKI) | Drug | Tyrosine Kinase Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pioglitazone & TKI therapy
- description
- Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Pioglitazone
- Drug: Tyrosine Kinase Inhibitor (TKI)
Primary outcomes (2)
- measure
- Incidence of Adverse Events (AEs), Graded According to Common Terminology Criteria for Adverse Events Version 4.03
- timeFrame
- Up to 30 days after the end of treatment
- description
- The AE incidence will be described. An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. AEs will be assessed through scheduled assessments and subject reported diaries.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Chronic myeloid leukemia (CML) in any phase * Philadelphia chromosome positive acute lymphoblastic leukemia * Loss of major molecular response (MMR) following a first TKI discontinuation trial * Serum bilirubin \< 1.5 x upper limit of normal values * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x 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 potential must have a negative urine pregnancy test at the time of enrollment; acceptable methods of birth control include oral contraceptive, intrauterine device, transdermal/implanted or injected contraceptives and abstinence * 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 * Patient requiring anti-diabetic medications to manage hyperglycemia are eligible. Adjustments of other anti-diabetic agents will be made with close monitoring of blood glucose * Informed consent * Be able and willing to comply with study visits and procedures Exclusion Criteria: * Known loss of complete cytogenetic response (CCyR) by marrow cytogenetic or blood fluorescence in situ hybridization (FISH) for breakpoint cluster region (BCR)- v-abl Abelson murine leukemia viral oncogene homolog 1 (ABL1) * Loss of complete hematologic response (CHR) * Participation in another clinical trial with any investigative drug within 30 days prior to study enrollment * Chronic graft-versus-host disease requiring systemic immunosuppression post-allogeneic hematopoietic stem cell transplantation * Cardiovascular disease: history of congestive heart failure, myocardial infarction in the 6 months preceding study entry, symptomatic cardiac arrhythmia requiring treatment * History of bladder cancer * Gross (visible) hematuria * Known history of osteoporosis * Known history of macular edema * Known history of ABL1-domain mutation that predicts resistance to the discontinued TKI * Significant medical or psychiatric disorder that would interfere with consent, study participation, or follow-up * Known allergy to pioglitazone * Pregnant or breastfeeding * Use of thiazolidinedione (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 * Active cancer that requires therapy in the form of chemotherapy or radiation
References
Publications (0)
Data not yet available