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A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients (IDEAL)

Primary Purpose

Chronic Myeloid Leukemia

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
600mg/day of Imatinib
400mg/day of Imatinib
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group B

Group A

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

CCyR in group A and B
CCyR rate for 12 months and the duration of the complete CCyR will be evaluated.
MMR in group A and B
MMR rate for 12 months and the duration of MMR will be measured.
CMR in group A and B
Survival rate in group A and B
Progression rate to AP/BC in group A and B
the actual administration
the total dose will be divided by total days of the treatment.

Full Information

First Posted
July 29, 2014
Last Updated
June 14, 2018
Sponsor
Dong-A ST Co., Ltd.
Collaborators
SeoulCRO
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1. Study Identification

Unique Protocol Identification Number
NCT02204722
Brief Title
A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients
Acronym
IDEAL
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision to halt the study.
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
May 23, 2017 (Actual)
Study Completion Date
January 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
Collaborators
SeoulCRO

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
600mg/day of Imatinib
Intervention Type
Drug
Intervention Name(s)
400mg/day of Imatinib
Primary Outcome Measure Information:
Title
MMR rate at 12 months in two groups
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CCyR in group A and B
Description
CCyR rate for 12 months and the duration of the complete CCyR will be evaluated.
Time Frame
12 months
Title
MMR in group A and B
Description
MMR rate for 12 months and the duration of MMR will be measured.
Time Frame
12 months
Title
CMR in group A and B
Time Frame
12 months
Title
Survival rate in group A and B
Time Frame
12 months
Title
Progression rate to AP/BC in group A and B
Time Frame
12 months
Title
the actual administration
Description
the total dose will be divided by total days of the treatment.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Hyoung Lee, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin-hee Park, M.D.
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chul-won Choi, M.D.
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sae-ryun Lee, M.D.
Organizational Affiliation
Korea University Ansan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong Park, M.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joo-sup Joeng, M.D.
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung-ok Lee, M.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chul-won Jung, M.D.
Organizational Affiliation
Seoul Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung-soo Yoon, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyung-ha Kim, M.D.
Organizational Affiliation
Soonchunhyang University Hospital Seoul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joon-sung Park, M.D.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Duk-yeon Cho, M.D.
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung-nam Im, M.D.
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients

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