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Study to compare efficacy & safety of Dasatinib with respect to Imatinib in newly diagnosed cases of chronic phase of chronic myeloid leukemia in terms of early response assessment at three months of therapy

Comparison of Efficacy & Safety of Dasatinib versus Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia with Reference to Early Molecular Response An Exploratory Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041208
Enrollment
80
Registered
2022-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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: Tablet Dasatinib: Tablet Dasatinib 100 mg per oral once daily ( or 60 mg/square meter body surface area/day for patients with age 18 years) for 3 months for study duration Control Inte

Sponsors

aiims rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Study Population: Newly diagnosed chronic phase chronic myeloid leukemia patients who fulfil inclusion criteria will be enrolled in the study. Inclusion Criteria: • Newly diagnosed patients with chronic phase CML. • Age >= 12 years, both males & females. • Patients willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: • Patients with de novo accelerated phase or blast phase CML. • Patients who have already started any tyrosine kinase inhibitor (TKI) treatment prior to randomization (Hydroxyurea started for initial cytoreduction is permitted). • Pregnancy. • Lactation. • Patients with pre-existing pleural effusion, grade >= 3 lung disease, or pulmonary arterial hypertension. • Patients with angina, or grade >= 3 cardiac disease[as defined by the New York Heart Association (NYHA) criteria] at diagnosis. • Patients with prolonged QTc interval ( > 480 msec) at baseline, or taking any concomitant medication known to prolong QTc interval.

Design outcomes

Primary

MeasureTime frame
1. To compare achievement of early molecular response (EMR) [defined as BCR-ABL1 transcript level â?¤ 10%, I.S.]at 3 months of therapywith Dasatinib versus Imatinibin newly diagnosed CML-CP patients.Timepoint: 1. To compare achievement of early molecular response (EMR) [defined as BCR-ABL1 transcript level â?¤ 10%, I.S.]at 3 months of therapywith Dasatinib versus Imatinibin newly diagnosed CML-CP patients.—

Secondary

MeasureTime frame
1. To compare achievement of complete hematological response (CHR) at 3 months of therapy in the two treatment groups. 2. To compare the adverse events in the two treatment groups. 3. To compare achievement of 2-log reduction in BCR-ABL1 transcript level [defined as BCR-ABL1 transcript level â?¤ 1 %, I.S.] at 3 months in the two treatment groups. Timepoint: 3 months—

Countries

India

Contacts

Public ContactSashi Kant Singh

AIIMS RISHIKESH

uttam.haemat@aiimsrishikesh.edu.in

Outcome results

None listed

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