Health Condition 1: null- Chronic phase Cytomyeloblastic leukemia treatment naive patients.
Conditions
Interventions
Intervention1: Not applicable: Not applicable
Control Intervention1: Not applicable: Not applicable
Sponsors
Terry Fox Fooundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with chronic phase CML. 2.Willing to consent for the study. 3.Able to recieve imatinib for atleast 24 months.
Exclusion criteria
Exclusion criteria: 1.Blood collection performed out of the trough concentration time limits. 2.Poor compliance to treatment. 3.Consumed grapefruit or grape fruit products less than one week before sample collection for pharmacokinetics. 4.Consumed a CYP3A4 enzyme inducer or inhibitor or a p-glycoprotein substrate less than 14 days prior to pharmacokinetic blood draw.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetics of imatinib in Indian patients with the Western data.Timepoint: Not applicable;To study the correlation of steady state (day 29) pharmacokinetics of imatinib with major molecular response and toxicity in Indian patients in chronic phase CML.Timepoint: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To study the correlation of steady state imatinib pharmacokinetics with CYP3A4 genotype. 2.To assess the role of TDM in predicting response to imatinib. 3.to assess the appropriate time (day8 versus day 29) for TDM to predict response to imatinib therapy. 4.To observe the staedy state trough concentration of imatinib and its correlation with complete hematological and cytogenetic response. 5.To observe the staedy state trough concentration of imatinib and its correlation with rapidity of response and durability of response. 6.To study the differences in staedy state trough concentration of imatinib by age, weight, gender and Sokal risk group.Timepoint: NOt applicable | — |
Countries
India
Contacts
Public ContactDr Brijesh Arora
Outcome results
None listed