Clinical trial NCT02204722: A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: SeoulCRO
First posted: 2014-07-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: MMR rate at 12 months in two groups
timeFrame: 12 months
Secondary outcomes:
measure: CCyR in group A and B
timeFrame: 12 months
measure: MMR in group A and B
timeFrame: 12 months
measure: CMR in group A and B
timeFrame: 12 months
measure: Survival rate in group A and B
timeFrame: 12 months
measure: Progression rate to AP/BC in group A and B
timeFrame: 12 months
measure: the actual administration
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyu-Hyoung Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University Gil Medical Center
name: Jin-hee Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: Chul-won Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Ansan Hospital
name: Sae-ryun Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Yong Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Joo-sup Joeng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Jung-ok Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul Medical Center
name: Chul-won Jung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Sung-soo Yoon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital Seoul
name: Kyung-ha Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Joon-sung Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: Duk-yeon Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Haeundae Paik Hospital
name: Sung-nam Im, M.D.
role: PRINCIPAL_INVESTIGATOR
References: