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

October 22, 2010 updated by: Uppsala University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, S-75185
        • Bengt Simonsson
      • Uppsala, Sweden, S-753 20
        • Uppsala University Hospital
      • Uppsala, Sweden, S-75320
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of rate Major Molecular Response between treatment arms
Time Frame: 2004 - 2009
Molecular response
2004 - 2009

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of complete cytogenetic response between the treatment arms at 12 months
Time Frame: 2004 - 2009
Cytogenetic response
2004 - 2009
Comparison rate complete cytogenetic response between the treatment arms at 12 months
Time Frame: 2004 - 2009
Hematologic response
2004 - 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska University Hospital
Uppsala University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

October 25, 2010

Last Update Submitted That Met QC Criteria

October 22, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NordCML002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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