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OpenTrials
Completed

NCT Number: NCT01227356

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

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

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Key information

Conditions

Health Care Quality Bone Marrow Diseases Chronic Disease Disease Attributes Health Care Evaluation Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bengt Simonsson, Uppsala, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

imatinib and pegylated interferon

Drug

imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly

Other names: Gleevec, PegIntron

Primary outcomes

  1. Comparison of rate Major Molecular Response between treatment arms

    Time frame: 2004 - 2009

    Molecular response

Secondary outcomes

  1. Comparison of complete cytogenetic response between the treatment arms at 12 months

    Time frame: 2004 - 2009

    Cytogenetic response

  2. Comparison rate complete cytogenetic response between the treatment arms at 12 months

    Time frame: 2004 - 2009

    Hematologic response

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Karolinska University Hospital
  • Uppsala University Hospital

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 25, 2010
Registry last updated
Oct 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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