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

NCT ID: NCT01227356

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Health Care Quality Health Care Evaluation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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imatinb + pegIntron

Group Type EXPERIMENTAL

imatinib and pegylated interferon

Intervention Type DRUG

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

Interventions

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imatinib and pegylated interferon

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

Intervention Type DRUG

Other Intervention Names

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Gleevec PegIntron

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Uppsala University

Principal Investigators

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bengt NO Simonsson, MD, PhD

Role: STUDY_CHAIR

Uppsala University

Locations

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Bengt Simonsson

Uppsala, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NordCML002

Identifier Type: -

Identifier Source: org_study_id