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A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT01227356
Collaborator
Uppsala University Hospital (Other), Karolinska University Hospital (Other)
112
Enrollment
3
Locations
1
Arm
62
Duration (Months)
37.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly.

Primary endpoint: To compare at 12 months between the treatment arms the rate of Major Molecular Response (=99,9% tumour reduction) at 12 months

Condition or Disease Intervention/Treatment Phase
  • Drug: imatinib and pegylated interferon
 Phase 2

Detailed Description

130 patients registered, 112 randomized. 56 pats in each treatment arm. 12 months study duration. Rate of Major Molecular Response was at 12 months 53 vs 82 % (p=0.002) in favour of the combination arm.

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study Comparing Imatinib And Imatinib/Pegylated Interferon Alpha-2B in Newly Diagnosed Non-high Risk Chronic Myeloid Leukemia Patients in Complete Hematological Remission After Imatinib Induction Therapy
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: imatinb + pegIntron

Drug: imatinib and pegylated interferon
imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly
Other Names:
  • Gleevec
  • PegIntron

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of rate Major Molecular Response between treatment arms [2004 - 2009]

      Molecular response

    Secondary Outcome Measures

    1. Comparison of complete cytogenetic response between the treatment arms at 12 months [2004 - 2009]

      Cytogenetic response

    2. Comparison rate complete cytogenetic response between the treatment arms at 12 months [2004 - 2009]

      Hematologic response

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG < 2

    Exclusion Criteria:

    Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG > 2 Pregnancy

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bengt Simonsson Uppsala Sweden S-75185
    2 Uppsala University Hospital Uppsala Sweden S-753 20
    3 Uppsala University Hospital Uppsala Sweden S-75320

    Sponsors and Collaborators

    • Uppsala University
    • Uppsala University Hospital
    • Karolinska University Hospital

    Investigators

    • Study Chair: bengt NO Simonsson, MD, PhD, Uppsala University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01227356
    Other Study ID Numbers:
    • NordCML002
    First Posted:
    Oct 25, 2010
    Last Update Posted:
    Oct 25, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    Chronic myeloid leukemia, imatinib, interferon
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Interferons
    Imatinib Mesylate

    Study Results

    No Results Posted as of Oct 25, 2010