CMLPhase 2CMLNCT01216085
An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints
A Phase 2 study testing high-dose imatinib in people with CML and Imatinib, run by Novartis Pharmaceuticals at 1 site in South Korea.
Trial summary
This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- high-dose imatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Jul 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TOPS(CSTI571K2301) participant patients who are taking Glivec more than 400 mg daily as 30 July, 2010, the close date of TOPS
- Patients who provided written informed consent prior to participation to this study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Single Center Study of High-dose Treatment of Glivec® in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity) Study
This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described.
- Being tested
- high-dose imatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose imatinibDrug
Study patients will receive 400 mg twice daily oral administration in the morning and the evening.
| Study group | Role | What they receive |
|---|---|---|
| imatinib | Experimental | Study patients will receive 400 mg twice daily oral administration in the morning and the evening. Receives: Drug: high-dose imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major molecular response
Major molecular response achieved to Month 60 from the time of Glivec treatment
Measured: 60 months
Secondary outcomes (2)
progression-free survival
Besides Complete molecular response, complete and major cytogenetic response achieved, event-free survival, and survival without progression to AP/BC achieved to Month 60 from the time of Glivec treatment, Progression-free survival will be evaluated.
Measured: until 60 months
number of adverse events
compliance status and adverse events
Measured: until 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMLStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong-Wook Kim, MD, PhD, Principal investigator, Catholic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216085
- Sponsor's protocol ID
- CSTI571AKR23
- Acronym
- CML
- Status last verified
- Oct 2020
- First submitted
- 27 Sep 2010
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Single Center Study of High-dose Treatment of Glivec® in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity) Study
- ClinicalTrials.gov ID
- NCT01216085
- Acronym / sponsor ID
- CML / CSTI571AKR23
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 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.
This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imatinib | Experimental | Drug: high-dose imatinibStudy patients will receive 400 mg twice daily oral administration in the morning and the evening. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- TOPS(CSTI571K2301) participant patients who are taking Glivec more than 400 mg daily as 30 July, 2010, the close date of TOPS
- Patients who provided written informed consent prior to participation to this study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| high-dose imatinibStudy patients will receive 400 mg twice daily oral administration in the morning and the evening. | Drug | imatinib |
Primary outcome
Major molecular response
Time frame: 60 months
Major molecular response achieved to Month 60 from the time of Glivec treatment
2 secondary outcomes
progression-free survival
Time frame: until 60 months
number of adverse events
Time frame: until 60 months
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 10 Mar 2021.
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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.
Dong-Wook Kim, MD, PhD principal investigator
Catholic Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high-dose imatinib in people with CML and Imatinib, run by Novartis Pharmaceuticals at 1 site in South Korea.
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 2 inclusion and 0 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Major molecular response (time frame: 60 months). 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 10 Mar 2021.