An extension to a phase II study to determine the efficacy and safety of STI571 in patients with chronic myeloid leukemia who are refractory to or intolerant of interferon-alpha - N/A

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001397-92-GB

Enrollment

340

Registered

2005-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Philadelphia chromosome-opositive chronic myeloid leukamia in myeloid blast crisis

Interventions

Product Name: Glivec Product Code: STI571 Pharmaceutical Form: Capsule* INN or Proposed INN: Imatinib Current Sponsor code: STI571

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: As for original protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: AS for original protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: •To enable patients to have access to study drug and continue study treatment •To decrease data collection to include overall survival and serious adverse events ;Secondary Objective: ;Primary end point(s):	—

Countries

United Kingdom

Outcome results

None listed

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