To Study Effect of food containing fats with nilotinib drug levels in blood in patients of Chronic Myeloid Leukemia Chronic Phase
- Conditions
- Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
- Registration Number
- CTRI/2019/08/020899
- Lead Sponsor
- APPLIED FOR GRANT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <= 1.5 mg or creatinine clearance >=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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method