Chronic Myeloid LeukemiaPhase 4IDEALNCT02204722
A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients
A Phase 4 study testing 600mg/day of Imatinib and 400mg/day of Imatinib in people with Chronic Myeloid Leukemia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- 600mg/day of Imatinib and 400mg/day of Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2014to 9 Jan 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at the age of 18 or more
- newly diagnosed within three months as a Chronic Myeloid Leukemia
- with positive Philadelphia chromosome and appearance of BCR-ABL transcript
- with 0 - 2 of ECOG Performance Status
- with normal renal function
- with normal hepatic function
- able to understand and decide to involve the study
Who cannot join
- history of radiation therapy for more than 25% of bone marrow due to other malignant diseases
- history of other clinically relevant malignant tumors
- with bleeding disorders which are not related to leukemia
- evidence of clinically relevant cardiac dysfunction
- with severe disease which cannot be regulated by other organs
- a previous administration of Imatinib more than a week prior to the first dose.
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- participation in other drug study(eg. intervention trial) within 30 days prior to the screening visit
- HIV-infected
- females with pregnancy, childbearing or lactating potential
- other reasons determined by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/Day Depending on Early Molecular Response in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase
This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level after three month dosing and be maintained their dose of 400mg/day. On the other hand, the group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day. The superiority of the group B will be proved by evaluating the MMR rate of these two groups after 12 months of administeration of Imatinib.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- 600mg/day of Imatinib, 400mg/day of Imatinib
- 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.
600mg/day of ImatinibDrug
400mg/day of ImatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | the group who has more than 10% of the BCR-ABL(IS) level for three months will receive 600mg/day of Imatinib after three months. Receives: Drug: 600mg/day of Imatinib |
| Group A | Experimental | the group who has more than 10% of the BCR-ABL(IS) level for three months will maintain the dose, 400mg/day of Imatinib, after three months. Receives: Drug: 400mg/day of Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMR rate at 12 months in two groups
MMR rate at 12 months in two groups will be compared. Group A is consisted of patients with equal or less than 10% of BDR-ABL, Group B is consisted of patients with more than 10% of BDR-ABL.
Measured: 12 months
Secondary outcomes (6)
CCyR in group A and B
CCyR rate for 12 months and the duration of the complete CCyR will be evaluated.
Measured: 12 months
MMR in group A and B
MMR rate for 12 months and the duration of MMR will be measured.
Measured: 12 months
CMR in group A and B
Measured: 12 months
Survival rate in group A and B
Measured: 12 months
Progression rate to AP/BC in group A and B
Measured: 12 months
the actual administration
the total dose will be divided by total days of the treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study start13 Oct 2014
- Primary completion23 May 2017
- Study completion9 Jan 2018
Why it stopped: Sponsor's decision to halt the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SeoulCRO
- Responsible party
- Sponsor
- Investigators
- Kyu-Hyoung Lee, M.D., Principal investigator, Asan Medical CenterJin-hee Park, M.D., Principal investigator, Gachon University Gil Medical CenterChul-won Choi, M.D., Principal investigator, Korea University Guro HospitalSae-ryun Lee, M.D., Principal investigator, Korea University Ansan HospitalYong Park, M.D., Principal investigator, Korea University Anam HospitalJoo-sup Joeng, M.D., Principal investigator, Pusan National University HospitalJung-ok Lee, M.D., Principal investigator, Seoul National University Bundang HospitalChul-won Jung, M.D., Principal investigator, Seoul Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204722
- Sponsor's protocol ID
- IMA_CML_IV
- Acronym
- IDEAL
- Status last verified
- Jun 2018
- First submitted
- 29 Jul 2014
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/Day Depending on Early Molecular Response in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase
- ClinicalTrials.gov ID
- NCT02204722
- Acronym / sponsor ID
- IDEAL / IMA_CML_IV
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision to halt the study.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SeoulCRO
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 30 Jul 2014 (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 to evaluate efficacy and safety of Imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level after three month dosing and be maintained their dose of 400mg/day. On the other hand, the group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day. The superiority of the group B will be proved by evaluating the MMR rate of these two groups after 12 months of administeration of Imatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Drug: 600mg/day of Imatinibthe group who has more than 10% of the BCR-ABL(IS) level for three months will receive 600mg/day of Imatinib after three months. |
| Group A | Experimental | Drug: 400mg/day of Imatinibthe group who has more than 10% of the BCR-ABL(IS) level for three months will maintain the dose, 400mg/day of Imatinib, after three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- at the age of 18 or more
- newly diagnosed within three months as a Chronic Myeloid Leukemia
- with positive Philadelphia chromosome and appearance of BCR-ABL transcript
- with 0 - 2 of ECOG Performance Status
- with normal renal function
Key exclusion criteria (10 listed)
- history of radiation therapy for more than 25% of bone marrow due to other malignant diseases
- history of other clinically relevant malignant tumors
- with bleeding disorders which are not related to leukemia
- evidence of clinically relevant cardiac dysfunction
- with severe disease which cannot be regulated by other organs
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 |
|---|---|---|
| 600mg/day of Imatinib | Drug | Group B |
| 400mg/day of Imatinib | Drug | Group A |
Primary outcome
MMR rate at 12 months in two groups
Time frame: 12 months
MMR rate at 12 months in two groups will be compared. Group A is consisted of patients with equal or less than 10% of BDR-ABL, Group B is consisted of patients with more than 10% of BDR-ABL.
6 secondary outcomes
CCyR in group A and B
Time frame: 12 months
MMR in group A and B
Time frame: 12 months
CMR in group A and B
Time frame: 12 months
Survival rate in group A and B
Time frame: 12 months
Progression rate to AP/BC in group A and B
Time frame: 12 months
the actual administration
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Sponsor's decision to halt the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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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.
Kyu-Hyoung Lee, M.D. principal investigator
Asan Medical Center
Jin-hee Park, M.D. principal investigator
Gachon University Gil Medical Center
Chul-won Choi, M.D. principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 600mg/day of Imatinib and 400mg/day of Imatinib in people with Chronic Myeloid Leukemia, run by Dong-A ST Co., Ltd. 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 15 Jun 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Sponsor's decision to halt the study.). Results are not available in the source record.
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?
MMR rate at 12 months in two groups (time frame: 12 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 15 Jun 2018.