Open Label Randomised Trial of Low Dose Dasatinib (50 mg OD) vs Standard Dose Dasatinib (100 mg OD) vs Standard Dose Imatinib (400 mg OD) as First Therapy in Patients with Newly Diagnosed Hematologic Malignancy of Chronic Myeloid Leukemia - Chronic Phase
Phase 3
- Conditions
- Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
- Registration Number
- CTRI/2023/05/053188
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Treatment-naïve, newly diagnosed adults (>= 18 years of age) with CML-CP, coming to the Department of Hematology after the Ethical approval for the study is granted, and providing informed consent for inclusion in the study, will be included in the study
Exclusion Criteria
a. Blast-crisis disease at diagnosis
b. Pregnant female, breastfeeding female, or potential pregnancy
c. Serious uncontrolled medical disorders
d. Pre-existing renal or hepatic dysfunction
e. QTc > 450 msec
f. Major bleeding disorder unrelated to CML
g. Myocardial infarction <6 months before enrollment
h. Congestive heart failure <3 months before enrollment
i. Uncontrolled hypertension or cardiac disease
j. Previous or concurrent chemotherapy
k. Baseline pleural effusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method