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

An Open Label Randomized Study of Low Dose Dasatinib (50 mg OD) vs Standard Dose Dasatinib (100 mg OD) vs Standard Dose Imatinib (400 mg OD) as Upfront Therapy in Patients with Newly Diagnosed Chronic Myeloid Leukemia (CML) - Chronic Phase (CP)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053188

Enrollment

222

Registered

2023-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive

Interventions

Intervention1: Dasatinib 50 mg OD: Tyrosine kinase inhibitor Intervention2: Tab Imatinib 400 mg once daily given orally: Tyrosine kinase inhibitor, approved for use in patients with chronic myeloid le

Eligibility

Inclusion criteria

Inclusion criteria: Treatment-naÃ¯ve, 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

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 h. Congestive heart failure i. Uncontrolled hypertension or cardiac disease j. Previous or concurrent chemotherapy k. Baseline pleural effusion

Design outcomes

Primary

Measure	Time frame
To compare the number of patients achieving early molecular response EMR, defined by peripheral blood BCR-ABL1 IS less thna or equal to 10%, after completion of 3 months of therapy, in the three armsTimepoint: Completion of 3 months of therapy	—

Secondary

Measure	Time frame
1. Assess and compare the velocity of initial response to tyrosine kinase inhibitor by assessing the halving time (HT) and reduction ratio (RR) by appropriate statistical methodsTimepoint: After 3 months of completion of therapy;2. To assess cost-effectiveness of Dasatinib 50 mg OD as compared to the other two arms of therapy by calculating the per day cost of therapy over a period of 3 monthsTimepoint: After 3 months of completion of therapy;3. To compare the rates of achievement of major molecular response (MMR) after completion of 12 months o therapy, which is equivalent to BCR-ABL1 IS of less than or equal to 0.01%, among the patient in the three treatment armsTimepoint: After completion of 12 months of therapy	—

Measure

Time frame

1. Assess and compare the velocity of initial response to tyrosine kinase inhibitor by assessing the halving time (HT) and reduction ratio (RR) by appropriate statistical methodsTimepoint: After 3 months of completion of therapy;2. To assess cost-effectiveness of Dasatinib 50 mg OD as compared to the other two arms of therapy by calculating the per day cost of therapy over a period of 3 monthsTimepoint: After 3 months of completion of therapy;3. To compare the rates of achievement of major molecular response (MMR) after completion of 12 months o therapy, which is equivalent to BCR-ABL1 IS of less than or equal to 0.01%, among the patient in the three treatment armsTimepoint: After completion of 12 months of therapy

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Countries

India

Contacts

Public ContactDr Neelabh Nayan

AIIMS, New Delhi

julesconstant@gmail.com9868397231

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026