Study to compare efficacy & safety of Dasatinib with respect to Imatinib in newly diagnosed cases of chronic phase of chronic myeloid leukemia in terms of early response assessment at three months of therapy
- Conditions
- Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
- Registration Number
- CTRI/2022/03/041208
- Lead Sponsor
- aiims rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Study Population: Newly diagnosed chronic phase chronic myeloid leukemia patients who fulfil inclusion criteria will be enrolled in the study.
Inclusion Criteria:
•Newly diagnosed patients with chronic phase CML.
•Age >= 12 years, both males & females.
•Patients willing to provide written informed consent.
Exclusion Criteria:
•Patients with de novo accelerated phase or blast phase CML.
•Patients who have already started any tyrosine kinase inhibitor (TKI) treatment prior to randomization (Hydroxyurea started for initial cytoreduction is permitted).
•Pregnancy.
•Lactation.
•Patients with pre-existing pleural effusion, grade >= 3 lung disease, or pulmonary arterial hypertension.
•Patients with angina, or grade >= 3 cardiac disease[as defined by the New York Heart Association (NYHA) criteria] at diagnosis.
•Patients with prolonged QTc interval ( > 480 msec) at baseline, or taking any concomitant medication known to prolong QTc interval.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare achievement of early molecular response (EMR) [defined as BCR-ABL1 transcript level â?¤ 10%, I.S.]at 3 months of therapywith Dasatinib versus Imatinibin newly diagnosed CML-CP patients.Timepoint: 1.To compare achievement of early molecular response (EMR) [defined as BCR-ABL1 transcript level â?¤ 10%, I.S.]at 3 months of therapywith Dasatinib versus Imatinibin newly diagnosed CML-CP patients.
- Secondary Outcome Measures
Name Time Method 1.To compare achievement of complete hematological response (CHR) at 3 months of therapy in the two treatment groups. <br/ ><br>2.To compare the adverse events in the two treatment groups. <br/ ><br>3.To compare achievement of 2-log reduction in BCR-ABL1 transcript level [defined as BCR-ABL1 transcript level â?¤ 1 %, I.S.] at 3 months in the two treatment groups. <br/ ><br>Timepoint: 3 months