Evaluating the effects of tyrosine kinase inhibitors in chronic myeloid leukemia
Tyrosine Kinase Inhibitors of BCR/ABL: Pharmacokinetic and Pharmacogenetic Study in Patients Affected by Chronic Myeloid Leukemia. Evaluation of Efficacy and Tolerability
University of Pisa · NCT01860456
This study is testing how well two medications for chronic myeloid leukemia work and how different genetic factors might affect how patients respond to them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 412 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pisa (other) |
| Drugs / interventions | imatinib, nilotinib |
| Locations | 2 sites (Pisa and 1 other locations) |
| Trial ID | NCT01860456 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics and treatment efficacy of imatinib and nilotinib in patients with chronic myeloid leukemia (CML). It aims to understand how genetic variations and drug transporters affect the variability in drug response among patients. By analyzing the relationship between drug levels and treatment outcomes, the study seeks to identify optimal dosing strategies for improved patient care. Participants will be monitored for their adherence to treatment and will provide informed consent to be part of this observational study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are currently being treated with imatinib or nilotinib for chronic myeloid leukemia.
Not a fit: Patients under 18 or over 80 years old, or those unable to provide informed consent, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for patients with chronic myeloid leukemia, improving their response to therapy.
How similar studies have performed: Other studies have shown promising results in understanding the pharmacogenetics of tyrosine kinase inhibitors, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients affected by chronic myeloid leukemia * Age limits: 18-80 years * Male and female patients * Treatment with imatinib/nilotinib since at least 3 weeks * Optimal adherence * Signed informed consent Exclusion Criteria: * Age \<18 or \>80 years * Poor adherence * Inability to attend follow-up visits * Lack of signed informed consent Concomitant administration of other drugs will be allowed, but active pharmacological agents, their dose and duration of treatment should be recorded. Smoking is not considered an exclusion criterium, but it should be noticed and recorded
Where this trial is running
Pisa and 1 other locations
- Unit of Hematology, Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (RECRUITING)
- Division of Hematology and Transplants, University of Siena — Siena, Italy (RECRUITING)
Study contacts
- Principal investigator: Sara Galimberti, MD, PhD — Department of Clinical and Experimental Medicine, University of Pisa
- Study coordinator: Sara Galimberti, MD, PhD
- Email: sara.galimberti@med.unipi.it
- Phone: +39-050-992755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Myeloid Leukemia, Chronic myeloid leukemia, Imatinib, Nilotinib, Polymorphism, Single Nucleotide, Pharmacokinetics, ATP-Binding Cassette Transporters, SLC Transporters