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

Uppsala University112 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Health Care Quality Health Care Evaluation

Interventions

imatinib and pegylated interferonDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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 \-

Locations (3)

Bengt Simonsson

Uppsala, Sweden

Uppsala University Hospital

Uppsala, Sweden

Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

Comparison of rate Major Molecular Response between treatment arms

Molecular response

Time frame: 2004 - 2009

Secondary Outcomes

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

Cytogenetic response

Time frame: 2004 - 2009

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

Hematologic response

Time frame: 2004 - 2009

Data from ClinicalTrials.gov

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