Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: Dasatinib: 50MG ONCE DAILY FOR 12 MONTHS
Control Intervention1: Not applicable: Not applicable
Sponsors
Christian Medical College Vellore
Eligibility
Inclusion criteria
Inclusion criteria: a)Newly diagnosed Chronic phase Ph-chromosome positive chronic myeloid leukemia b)Diagnosed within 3 months before study entry and no previous treatment for CML except for hydroxyurea c)Age above 18 years d)Eastern Co-operative Oncology Group (ECOG) score of 2 or less e)Adequate hepatic and renal function (total Bilirubin level of less than 2 times the upper limit of normal, serum aspartate and alanine aminotransferase of less than 2.5 times the upper limit of normal and serum Creatinine of 3 times the upper limit of normal range) f)Women of reproductive age wiling to use contraception while on Dasatinib. g)Willing to consent for the study h)Available for follow up
Exclusion criteria
Exclusion criteria: a)Pregnancy b)Breastfeeding c)History of congestive heart failure, Left ventricular dysfunction, myocardial infarction, pleural disease or chronic lung disease d)Bleeding diathesis e)QTc prolongation on baseline ECG (corrected QTc more than 450msec) f)Concomitant therapy with CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) or inducers (dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital), antacids, proton pump inhibitors and H2 antagonists g)Active infections h)Previous or concurrent cancer (other than basal-cell carcinoma skin), adequately treated stage I/II cancer and in remission or any other cancer and been disease free for 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year complete cytogenetic response rateTimepoint: 1-year complete cytogenetic response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety as per NCI CTCAE v.5, 1-year major molecular response rate, â?¢Overall survival, â?¢Event-free survival with event being defined as disease progression (to accelerated or blast phase) or deathTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactAby Abraham
Christian Medical College, Vellore
Outcome results
None listed