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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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.

Show all 10Show fewer

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.

South Korea1 site

Asan Medical Center
Seoul, 138736

Other trials in South Korea

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 groups in NCT02204722
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.

13 Oct 20149 Jan 2018

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

All Chronic Myeloid Leukemia trials

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.

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.

Related trials for Chronic Myeloid Leukemia

RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

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?

On the ClinicalTrials.gov record for NCT02204722.

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; AzTrials last refreshed its copy on 7 Nov 2026.