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An extension to a phase II study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome-positive leukemia including acute lymphoblastic leukaemia, acute myeloid leukaemia, and accelerated phase chronic myeloid leukemia - N/A

An extension to a phase II study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome-positive leukemia including acute lymphoblastic leukaemia, acute myeloid leukaemia, and accelerated phase chronic myeloid leukemia - N/A

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001396-19-GB
Enrollment
59
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

Sponsors

Novartis Pharmaceuticals UK Ltd
Lead Sponsor

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

MeasureTime 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