Text Size

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:

U.S. FDA Resources

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

-

  Contacts and Locations
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 May 22, 2013