Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia

Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia - NA

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

LBCTR

Registry ID

LBCTR2019010169

Enrollment

100

Registered

2021-09-10

Start date

2019-03-07

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Early Chronic Phase Chronic Myeloid Leukemia

Interventions

dasatinib 50 mg QD or dasatinib 100 mg QD

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age = 18 years. Diagnosis of Ph+ or BCR-ABL positive CML in early CP (i.e. time from diagnosis <12 months). Clonal evolution ECOG performance of 0-2. Adequate end organ function

Exclusion criteria

Exclusion criteria: NYHA cardiac class 3-4 heart disease Cardiac symptoms History of significant bleeding disorder Patients with active uncontrolled psychiatric disorders Pregnant or breast-feeding women Patients in late chronic phase (i.e. time from diagnosis to treatment >12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase

Outcome results

None listed

Source: LBCTR (via WHO ICTRP) · Data processed: Feb 7, 2026