Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. CML patients receiving dasatinib due to either imatinib failure or toxicity. 2. Male and female patients of age >=5 years 3. ECOG performance of 0-2. 4. Patients willing to sign the informed consent form or assent form (whichever is applicable)
Exclusion criteria
Exclusion criteria: 1. Patient unwilling to provide blood samples necessary for the study. 2. Patients in Accelerated Phase or Blast crisis in medullary or extra-medullary sites 3. Patients receiving other intensive chemotherapy. 4. Children less than 5 years of age 5. Any clinical condition which the treating physician opines that dasatinib is not safe/effective for the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dasatinib pharmacokinetic parameters (Cmax, Ctrough, AUC0-â??, t1/2)Timepoint: blood samples on Day 1 at 0,0.25,0.5,1.1.5,2,3,4,5,6,8 hrs and 2 blood samples at follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Covariates affecting the Dasatinib pharmacokinetic parametersTimepoint: 18 - 24 months;Covariates other than pharmacokinetic parameters that may be responsible for occurrence of pleural effusion in CML patients receiving dasatinibTimepoint: 18-24 months;Major molecular Response (MMR): Percentage of patients achieving MMR at the end of 12 months of treatment with dasatinib. MMR is defined as a BCR-ABL1 expression of â?¤0.1%.Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactManjunath Nookala Krishnamurthy
Advanced Centre for Treatment, Research and Education- Tata Momorial Centre
Outcome results
None listed