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A Phase III Study of Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase CML

An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2007/091/000023
Enrollment
Unknown
Registered
2008-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Dasatinib: Intervention2: A: Experimental: Drug: Dasatinib Tablets, oral, dasatinib 50-180 mg QD, once daily, 5-7 years Control Intervention1: B: Active: Drug: Imatinib Tablets, oral,

Sponsors

The pharmaceutical company sponsoring this study is Bristol-Myers Squibb
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: �� Male & Female ≥18 years �� CP Ph+ CML �� ECOG PS 0-2

Exclusion criteria

Exclusion criteria: �� Pleural Effusion �� Uncontrolled CV disease �� Significant bleeding disorder unrelated to CML �� Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea

Design outcomes

Primary

MeasureTime frame
Best confirmed Complete Cytogenetic Response [Time Frame: at 12 months]Timepoint:—

Secondary

MeasureTime frame
Time in, duration and time to confirmed CCyR �� Time in duration and time to confimred CCyR [Time Frame: within 12 months]Timepoint:—

Countries

India

Contacts

Public ContactDr Manishkumar D Shah

Medical Director

manish.mistry@bms.com+912266288710

Outcome results

None listed

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