Drug monitoring method for Dasatinib in blood cancer patients
Not Applicable
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2020/09/027561
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>2 blood samples at follow-up
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br> <br/ ><br>