FindTrial
Sign In

An extension to a phase II open label study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome positive chronic myeloid leukemia in myeloid blast crisis

An extension to a phase II open label study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome positive chronic myeloid leukemia in myeloid blast crisis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001380-61-IT
Enrollment
260
Registered
2007-03-02
Start date
2005-04-15
Completion date
Unknown
Last updated
2013-12-09

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

Conditions

Ph+ CML in myeloid blast crisis MedDRA version: 14.1 Level: PT Classification code 10009013 Term: Chronic myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: GLIVEC Pharmaceutical Form: Film-coated tablet INN or Proposed INN: imatinib Concentration unit: mg milligram(s) Concentration number: 100- Trade Name: GLIVEC Pharmaceutical Form: Film-co

Sponsors

NOVARTIS FARMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Refer to the original protocol for details of inclusion and exclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: 0 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Refer to the original protocol for details of inclusion and exclusion criteria.

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 only overall survival and serious adverse events;Secondary Objective: NA;Primary end point(s): Overall survival—

Countries

Italy

Outcome results

None listed

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