NCT01227356

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
Last Updated

October 25, 2010

Status Verified

October 1, 2010

Enrollment Period

4.5 years

First QC Date

October 22, 2010

Last Update Submit

October 22, 2010

Conditions

Health Care QualityHealth Care Evaluation

Keywords

Chronic myeloid leukemia, imatinib, interferon

Outcome Measures

Primary Outcomes (1)

  • Comparison of rate Major Molecular Response between treatment arms

    Molecular response

    2004 - 2009

Secondary Outcomes (2)

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

    2004 - 2009

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

    2004 - 2009

Study Arms (1)

imatinb + pegIntron

EXPERIMENTAL
Drug: imatinib and pegylated interferon

Interventions

imatinib and pegylated interferonDRUG

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

Also known as: Gleevec, PegIntron
imatinb + pegIntron

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG \< 2

You may not qualify if:

  • Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG \> 2 Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bengt Simonsson

Uppsala, S-75185, Sweden

Location

Uppsala University Hospital

Uppsala, S-753 20, Sweden

Location

Uppsala University Hospital

Uppsala, S-75320, Sweden

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylatepeginterferon alfa-2b

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • bengt NO Simonsson, MD, PhD

    Uppsala University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

September 1, 2004

Primary Completion

March 1, 2009

Study Completion

November 1, 2009

Last Updated

October 25, 2010

Record last verified: 2010-10

Locations

SE(3)