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

Health Care Quality Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227356
• Other study ID #: NordCML002
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2010
• Last updated: October 22, 2010
• Start date: September 2004
• Est. completion date: November 2009

Study information

• Verified date: October 2010
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health Care Evaluation
• Health Care Quality
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• imatinib and pegylated interferon
imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly

Locations

Country	Name	City	State
Sweden	Bengt Simonsson	Uppsala
Sweden	Uppsala University Hospital	Uppsala
Sweden	Uppsala University Hospital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Karolinska University Hospital, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of rate Major Molecular Response between treatment arms	Molecular response	2004 - 2009	Yes
Secondary	Comparison of complete cytogenetic response between the treatment arms at 12 months	Cytogenetic response	2004 - 2009	Yes
Secondary	Comparison rate complete cytogenetic response between the treatment arms at 12 months	Hematologic response	2004 - 2009	Yes