Health Care QualityPhase 2NCT01227356
A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia
A Phase 2 study testing imatinib and pegylated interferon in people with Health Care Quality and Health Care Evaluation, run by Uppsala University at 3 sites in Sweden.
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 Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Health Care Quality, Health Care Evaluation
- What is being tested?
- imatinib and pegylated interferon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 3 sitesSweden
- Study dates
- Sep 2004to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG < 2
Who cannot join
- Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG > 2 Pregnancy
- -
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Bengt Simonsson
Uppsala, S-75185
Uppsala University Hospital
Uppsala, S-753 20
Uppsala University Hospital
Uppsala, S-75320
About this study
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
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
Read the detailed 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.
- Conditions
- Health Care Quality, Health Care Evaluation
- Being tested
- imatinib and pegylated interferon
- Keywords
- Chronic myeloid leukemia, imatinib, interferon
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib and pegylated interferonDrug
Also called Gleevec, PegIntron
imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly
| Study group | Role | What they receive |
|---|---|---|
| imatinb + pegIntron | Experimental | Not described Receives: Drug: imatinib and pegylated interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of rate Major Molecular Response between treatment arms
Molecular response
Measured: 2004 - 2009
Secondary outcomes (2)
Comparison of complete cytogenetic response between the treatment arms at 12 months
Cytogenetic response
Measured: 2004 - 2009
Comparison rate complete cytogenetic response between the treatment arms at 12 months
Hematologic response
Measured: 2004 - 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startSep 2004
- Primary completionMar 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care QualityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Karolinska University Hospital
- Investigators
- bengt NO Simonsson, MD, PhD, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227356
- Sponsor's protocol ID
- NordCML002
- Status last verified
- Oct 2010
- First submitted
- 22 Oct 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01227356
- Acronym / sponsor ID
- NordCML002
- Conditions
- Health Care Quality, Health Care Evaluation
- Keywords
- Chronic myeloid leukemia, imatinib, interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Karolinska University Hospital
- Study start
- Sep 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imatinb + pegIntron | Experimental | Drug: imatinib and pegylated interferon |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG < 2
Key exclusion criteria (2 listed)
- Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG > 2 Pregnancy
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imatinib and pegylated interferonAlso: Gleevec, PegIntronimatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly | Drug | imatinb + pegIntron |
Primary outcome
Comparison of rate Major Molecular Response between treatment arms
Time frame: 2004 - 2009
Molecular response
2 secondary outcomes
Comparison of complete cytogenetic response between the treatment arms at 12 months
Time frame: 2004 - 2009
Comparison rate complete cytogenetic response between the treatment arms at 12 months
Time frame: 2004 - 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bengt NO Simonsson, MD, PhD study chair
Uppsala University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing imatinib and pegylated interferon in people with Health Care Quality and Health Care Evaluation, run by Uppsala University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of rate Major Molecular Response between treatment arms (time frame: 2004 - 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2010.