Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: giving nilotinib with food: Patients will be divided in 5 cohorts in non-randomized pattern.
1. Cohort 1 will be given a dose of nilotinib 150 mg OD empty stomach for 8 days followed b
Sponsors
APPLIED FOR GRANT
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in age group 18-65 years 2. Patients with newly diagnosed Chronic Myeloid leukemia in CML-CP phase as diagnosed with Bone marrow aspiration, peripheral smear, Philadelphia chromosome and RT-PCR BCR-ABL. 3. Serum albumin Levels > 3.5 gm/dl 4. Patients who provide written informed consent 5. ECOG performance status 0 â?? 2. 6. Serum creatinine =60 ml/min. 7. Serum bilirubin < 1.5 UNL, AST/ALT < 3 UNL 8. Able to understand the PIS (patient information sheet and give informed consent)
Exclusion criteria
Exclusion criteria: 1. Patients who are not willing to participate and will not provide signed informed consent 2. Uncontrolled DM, defined as HbA1c greater than 7.5 3. Patients with hepatic dysfunction that is those in whom serum bilirubin will be more than 1.5 times of upper normal limit and, AST and ALT will be more than 3 fold higher than the upper limit of normal at baseline 4. Patients in whom serum creatinine will be more than 1.6 or creatinine clearance less then 60 5. Patients taking strong CYP2D6 and CYP3A4 inducer or inhibitor available from Metabolism and Transport Drug Interaction Database 6. Patients taking drugs that are known to cause QT prolongation. 7. Patients having Qtc interval greater then 440 msec as calculated by bazett formula. 8. Presence of Active infection 9. ECOG performance status 3-4. 10. History of any gastric malabsorption disorder/ gastric/ intestinal surgery 11. Uncontrolled hypertension (systolic BP greater than 160 mmHg or diastolic BP greater than 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment 12. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease 13. Patients with pancreatic dysfunction /prior history of pancreatitis and with increased amylase levels more than normal limits. 14. Administration of an investigational therapeutic agent within 30 days of screening 15. Active psychiatric illnesses/social situations that would limit compliance with protocol requirements 16. Presence of Hepatitis B/HIV/ Hep C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Drug levels of Nilotinib assessed by HPLC-mass spectroscopy.Timepoint: The specified time points of limited sampling technique at pre dose ie 0 hr, 1 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 16 hrs, 20 hrs and 24hrs on day 1 each of fasting and fed state of each cohort. On day 8, samples will be taken at 0 and 3 hour interval in each of fasting and fed state of each cohort. | — |
Secondary
| Measure | Time frame |
|---|---|
| to monitor low dose nilotinib with food produces same clinical benefit by correlating itâ??s in vivo activity with markers as BCR-ABL, STAT1, STAT5 and CRKLTimepoint: samples to be taken at day 1 and day 8 of each cohort | — |
Countries
India
Contacts
Public ContactANKUR NANDAN VARSHNEY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed