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Clinical Trials/EUCTR2004-001622-24-IE
EUCTR2004-001622-24-IE
Active, not recruiting
Phase 1

Phase III,multicentre,open-label,prospective randomised trial comparing Imatinib alone at 400mg versus 800mg daily versus Imatinib 400mg daily plus PEG Interferon-alpha with newly diagnosed chronic myeloid leukaemia - Spirit

ewcastle Hospital Trust0 sites259 target enrollmentJanuary 19, 2005
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ConditionsChronic Myeloid Leukaemia (Chronic Phase)
DrugsGlivec (400mg)Glivec (800mg)Pegasys

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic Myeloid Leukaemia (Chronic Phase)
Sponsor
ewcastle Hospital Trust
Enrollment
259
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 19, 2005
End Date
January 15, 2014
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
ewcastle Hospital Trust

Eligibility Criteria

Inclusion Criteria

  • •Within 3 months of initial diagnosis of chronic myeloid leukaemia in chronic phase
  • •Previously intreated with the exception of hydroxyurea and/or anagrelide
  • •Cytogenetic confirmation of Philadelphia chromosome or variants of (9;22\) translocations
  • •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) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients with PH\-negative,BCR\-ABL positive disease are NOT eligible

Outcomes

Primary Outcomes

Not specified

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