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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001382-33-IT

Enrollment

530

Registered

2005-06-22

Start date

2005-04-15

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

treatment of patients with CML who are refractory to or intolerant of interferon alpha. MedDRA version: 14.1 Level: LLT Classification code 10052065 Term: Chronic phase chronic myeloid leukaemia System Organ Class: 100000004864

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: ? To decrease the frequency of bone marrow evaluations to once a year from once every 6 months for all patients who have achieved a complete cytogenetic response. This study objective has been met as of protocol extension 2 amendment 1. ? To enable patients to continue to have access to study treatment ? To decrease data collection after month 48 of the extension phase to include only overall survival and serious adverse events;Secondary Objective: na;Primary end point(s): Overall survival	—

Measure

Time frame

Main Objective: ? To decrease the frequency of bone marrow evaluations to once a year from once every 6 months for all patients who have achieved a complete cytogenetic response. This study objective has been met as of protocol extension 2 amendment 1. ? To enable patients to continue to have access to study treatment ? To decrease data collection after month 48 of the extension phase to include only overall survival and serious adverse events;Secondary Objective: na;Primary end point(s): Overall survival

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Countries

Italy

Outcome results

None listed

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