Chronic Myeloid LeukemiaPhase 4NCT02317159

Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia

A Phase 4 study testing Imatinib in people with Chronic Myeloid Leukemia, run by Cttq.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in patients with chronic phase of Chronic Myeloid Leukemia. 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?: Imatinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: No sites listed yet
Study dates: Feb 2015to Jul 2017
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

Age≥18；
The new diagnosis of CML patients in six months；
No proof of extra-medullary infiltration of leukemia；
ECOG PS score：0-2；
Hepatic and renal functions are normal，Serum bilirubin≤1.5*ULN, serum ALT and AST≤2.5*ULN, serum Cr≤1.5*ULN;
Do not receive the treatment of anti-CML；
Subjects signed informed consent form in line with GCP requirements。

Who cannot join

Pregnant or lactating women；
Received TKIs any time before；
Failure to control systemic infection or multiple organ failure；
According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；
Being diagnosed with other malignancies in the prior 12 months；
Have a history of neurological or psychiatric disorders, including epilepsy or dementia；

Show all 9Show fewer

Known or suspected allergy to imatinib；
BSA≤1.5m2；
Using other experimental drugs or participating in other clinical trials in the prior one months。

Trial locations and contacts

No sites are listed yet.

Zhixiang Shen, Master contact

13901651262

About this study

This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in patients with chronic phase of Chronic Myeloid Leukemia.

Conditions: Chronic Myeloid Leukemia
Being tested: 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.

ImatinibDrug
400mg imatinib qd PO

Study groups in NCT02317159
Study group	Role	What they receive
imatinib，Capsule	Experimental	400mg imatinib qd Receives: Drug: Imatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

major molecular response
the rate of major molecular response in two years
Measured: 2 years

Secondary outcomes (3)

complete cytogenetics response
the rate of complete cytogenetics response in one years
Measured: 1 years
over survival
the rate of over survival in two years
Measured: 2 years
progress free survival
the rate of progress free survival in two years
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Jul 2017

First posted15 Dec 2014 (estimated)
Study startFeb 2015
Primary completionJun 2017 (estimated)
Study completionJul 2017 (estimated)

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02317159
Sponsor's protocol ID: IMAGE-201
Status last verified: Dec 2014
First submitted: 11 Dec 2014
Last updated: 15 Dec 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

Zhixiang Shen, Master

13901651262

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 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia
ClinicalTrials.gov ID: NCT02317159
Acronym / sponsor ID: IMAGE-201
Conditions: Chronic Myeloid Leukemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 90 participants (estimated)
Lead sponsor: CttqIndustry (pharma, biotech, devices)
Collaborators: Ruijin Hospital
Study start: Feb 2015
Primary completion: Jun 2017 (estimated)
Study completion: Jul 2017 (estimated)
First posted: 15 Dec 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 is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in patients with chronic phase of Chronic Myeloid Leukemia.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
imatinib，Capsule	Experimental	Drug: Imatinib400mg imatinib qd

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age≥18；
The new diagnosis of CML patients in six months；
No proof of extra-medullary infiltration of leukemia；
ECOG PS score：0-2；
Hepatic and renal functions are normal，Serum bilirubin≤1.5*ULN, serum ALT and AST≤2.5*ULN, serum Cr≤1.5*ULN;

Key exclusion criteria (9 listed)

Pregnant or lactating women；
Received TKIs any time before；
Failure to control systemic infection or multiple organ failure；
According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；
Being diagnosed with other malignancies in the prior 12 months；

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
Imatinib400mg imatinib qd PO	Drug	imatinib，Capsule

Primary outcome

major molecular response
Time frame: 2 years
the rate of major molecular response in two years

3 secondary outcomes

complete cytogenetics response
Time frame: 1 years
over survival
Time frame: 2 years
progress free survival
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.

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.

Zhixiang Shen, Master contact

13901651262

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Imatinib in people with Chronic Myeloid Leukemia, run by Cttq.

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 9 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: status not confirmed, as of the sponsor's last update on 15 Dec 2014. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhixiang Shen, Master (13901651262), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

major molecular response (time frame: 2 years). 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 NCT02317159.

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 Dec 2014.