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An extension to a phase II study to determine the safety and the anti- leukemic effects of STI571 in adults patients with Philadelphia chromosome positive leukemia including acute lymphoblastic leukemia, acute myeloid leukemia and accelerate phase myeloid leukemia.

An extension to a phase II study to determine the safety and the anti- leukemic effects of STI571 in adults patients with Philadelphia chromosome positive leukemia including acute lymphoblastic leukemia, acute myeloid leukemia and accelerate phase myeloid leukemia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001381-14-IT
Enrollment
294
Registered
2005-06-22
Start date
2005-08-02
Completion date
Unknown
Last updated
2014-02-10

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

Conditions

Philadelphia chromosome positive leukemia including acute lymphoblastic leukemia, acute myeloid leukemia and accelerate phase myeloid leukemia. MedDRA version: 14.1 Level: HLT Classification code 10024296 Term: Leukaemias chronic myeloid System Organ Class: 100000004851

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 overall study design. 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 overall study design.

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