Optimizing Chronic Myeloid Leukemia Treatment: a Randomized Phase II Trial of Upfront Low-Dose Nilotinib in the Indian Context

INTERVENTION: Intervention1: NILOTINIB: NILOTIINIB 150 MG TWICE DAILY FOR 3 MONTHS Control Intervention1: IMATINIB: IMATINIB 400 MG ONCE DAILY FOR 3 MONTHS CONDITION: Health Condition 1: C921‐ Chronic myeloid leukemia, BCR/ABL‐positive PRIMARY OUTCOME: To compare the efficacy of Low‐dose Nilotinib versus Imatinib for attainment of Early Molecular response three months BCR‐ABL IS ratio less than 10% in previously untreated newly Diagnosed CML Chronic phase PatientsTimepoint: 3 MONTHS SECONDARY OUTCOME: To calculate the proportion of patients who will achieve CHR at the end of three months of intervention ; ; To evaluate the safety profile of low‐dose nilotinib arm and Imatinib in patients with cml in chronic phase CP patients ; ; To evaluate the number of patients who have relapsed or failed treatment during the course of intervention ; ; Adherence with therapy which is Self‐reported ; Timepoint: 3 months INCLUSION CRITERIA: Male or female patients more than or equal to 18 years of age Patients with newly diagnosed Chronic Myeloid leukaemia in the CML‐CP phase as diagnosed with Bone marrow aspiration or peripheral smear or Philadelphia chromosome Qualitative RT‐PCR BCR‐ABL Serum albumin Levels more than 3.5 gm per decilitre Patients who provide written informed consent prior to any study‐related screening procedures being performed ECOG performance status up to 2 Serum creatinine less than1.5 mg or creatinine clearance more than or equal to 60 ml/min as per the Cockroft‐Gault formula Serum bilirubin less than 1.5 Upper Normal Limit Serum AST and ALT less than three times Upper Normal Limit Able to understand the Patient information sheet and give informed consent Female patients of childbearing potential must have a negative serum pregnancy within seven days before initiation of the study