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

This study has been completed.
Sponsor:
Collaborators:
Uppsala University Hospital
Karolinska University Hospital
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT01227356
First received: October 22, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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 Intervention Phase
Health Care Quality
Health Care Evaluation
Drug: imatinib and pegylated interferon
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Comparison of rate Major Molecular Response between treatment arms [ Time Frame: 2004 - 2009 ] [ Designated as safety issue: Yes ]
    Molecular response


Secondary Outcome Measures:
  • Comparison of complete cytogenetic response between the treatment arms at 12 months [ Time Frame: 2004 - 2009 ] [ Designated as safety issue: Yes ]
    Cytogenetic response

  • Comparison rate complete cytogenetic response between the treatment arms at 12 months [ Time Frame: 2004 - 2009 ] [ Designated as safety issue: Yes ]
    Hematologic response


Enrollment: 112
Study Start Date: September 2004
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227356

Locations
Sweden
Uppsala University Hospital
Uppsala, Sweden, S-753 20
Bengt Simonsson
Uppsala, Sweden, S-75185
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 University of Uppsala
  More Information

No publications provided

Responsible Party: Bengt Simonsson/Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT01227356     History of Changes
Other Study ID Numbers: NordCML002
Study First Received: October 22, 2010
Last Updated: October 22, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Uppsala University:
Chronic myeloid leukemia, imatinib, interferon

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib
Interferons
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014