Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: DASATINIB 70 MG ONCE DAILY: patients will get dasatinib 70mg once daily in intervention arm . they will be followed on regular intervals to look for the any adverse events during study
Sponsors
Department of Medical Oncology Haematology
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed patients with chronic phase CML. 2.Age = 12 years, both males & females. 3.Patients willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with de novo accelerated phase or blast phase CML. 2.Patients who have already started any tyrosine kinase inhibitor (TKI) treatment prior to randomization (hydroxyurea for initial cytoreduction is permitted). 3.Pregnancy & lactation. 4.Patients with pre-existing pleural effusion, grade = 3 lung disease, or pulmonary arterial hypertension. 5.Patients with angina, or grade = 3 cardiac disease [as defined by the New York Heart Association (NYHA) criteria] at diagnosis. 6.Patients with prolonged QTc interval (( >480 msec) at baseline, or taking any concomitant medication known to prolong QTc interval.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the early molecular response rates [defined as BCR-ABL1 transcript level = 10%, I.S.] at 3 months of therapy in the two treatment groups. 2. To compare complete hematological response (CHR) rates at 3 months of therapy in the two treatment groups.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the adverse events in the two treatment groups as per NCI CTCAE version 5.Timepoint: anytime up to 3 months | — |
Countries
India
Contacts
Public ContactDr. Paras Satadeve
All India Institute of Medical Sciences (AIIMS), Rishikesh
Outcome results
None listed