Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: Tab Vildagliptin and Tab Dasatinib: Tab Vildagliptin 50mg BD for 6 months
Tab Dasatinib 50mg OD for 6 months
Control Intervention1: Tab Dasatinib: Tab Dasatinib 50mg OD for 6 months
Sponsors
DR ESWER SUBBAIYAN I
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients at or above 18 years of age diagnosed with chronic phase CML. 2. Treatment-naive patients. 3. ECOG Performance Status 0,1 or 2
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) 3. Patients with pre-existing pleural effusion, grade more than or equal to 3 lung disease, or pulmonary arterial hypertension. 4. Patients with angina, or grade more than or equal to 3 cardiac disease [as defined by the New York Heart Association (NYHA) criteria] at diagnosis. 5. Patients with prolonged QTc interval (more than 480 msec) at baseline, or taking any concomitant medication known to prolong QTc interval. 6. Patients who have Inflammatory Bowel Disease 7. Patients who have acute liver disease or cirrhosis 8. Patients who have previous or active acute or chronic pancreatic disease 9. Patients who are pregnant, breastfeeding, male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial 10. Patients who have known intolerance to vildagliptin 11. Patients with poorly controlled diabetes mellitus (HbA1c more than 9) 12. Patients with personal and/or family history of medullary carcinoma thyroid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparing Reduction in Peripheral Blood Leukemic Stem CellsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparing treatment related adverse eventsTimepoint: 6 months;Comparing molecular responseTimepoint: 6 months;Correlating leukemic stem cell level with disease related parametersTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr ESWER SUBBAIYAN I
AIIMS RISHIKESH
Outcome results
None listed