Chronic Myelogenous Leukemia in Chronic PhasePhase 3NCT00237120
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
A Phase 3 study testing Imatinib in people with Chronic Myelogenous Leukemia in Chronic Phase, run by Novartis.
Trial summary
This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML. Read more about this study
- Who is it for?
- Ages 15 to 74 years
- Conditions the study is for
- Chronic Myelogenous Leukemia in Chronic Phase
- What is being tested?
- Imatinib
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jun 2007
- Phase
- Phase 3
- 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 15 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
- Previously untreated with Interferon-alpha
- Performance status is normal or capable of only limited self-care
Who cannot join
- Patients who are pregnant or possibly pregnant
- Significant hepatic diseases
- Chronic Myelogenous Leukemia in advanced phase
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.
- Being tested
- Imatinib
- Keywords
- Chronic Myelogenous Leukemia, Imatinib, CML
- 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.
ImatinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
3 years overall survival
Duration of remaining in chronic phase
Secondary outcomes (2)
Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
Adverse event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startNov 2002
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous Leukemia in Chronic PhaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237120
- Sponsor's protocol ID
- CSTI571AJP02
- Status last verified
- Nov 2009
- First submitted
- 7 Oct 2005
- Last updated
- 23 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
- ClinicalTrials.gov ID
- NCT00237120
- Acronym / sponsor ID
- CSTI571AJP02
- Keywords
- Chronic Myelogenous Leukemia, Imatinib, CML
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jun 2007 (actual)
- First posted
- 12 Oct 2005 (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.
This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
- Previously untreated with Interferon-alpha
- Performance status is normal or capable of only limited self-care
Key exclusion criteria (4 listed)
- Patients who are pregnant or possibly pregnant
- Significant hepatic diseases
- Chronic Myelogenous Leukemia in advanced phase
- Other protocol-defined inclusion/exclusion criteria may apply.
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 | Drug | – |
Primary outcome
3 years overall survival
Duration of remaining in chronic phase
2 secondary outcomes
Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
Adverse event
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 23 Nov 2009.
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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.
Novartis study chair
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imatinib in people with Chronic Myelogenous Leukemia in Chronic Phase, run by Novartis.
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 3 inclusion and 4 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 23 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
3 years overall survival. The study lists 2 primary outcomes in all. 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 23 Nov 2009.