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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Myeloid Leukemia
• Intervention / Treatment: Drug: 600mg/day of Imatinib; Drug: 400mg/day of Imatinib

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group B; 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.	Drug: 600mg/day of Imatinib
Experimental: Group A; 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.	Drug: 400mg/day of Imatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Collaborators: SeoulCRO
• Investigators: Principal Investigator: Kyu-Hyoung Lee, M.D., Asan Medical Center; Principal Investigator: Jin-hee Park, M.D., Gachon University Gil Medical Center; Principal Investigator: Chul-won Choi, M.D., Korea University Guro Hospital; Principal Investigator: Sae-ryun Lee, M.D., Korea University Ansan Hospital; Principal Investigator: Yong Park, M.D., Korea University Anam Hospital; Principal Investigator: Joo-sup Joeng, M.D., Pusan National University Hospital; Principal Investigator: Jung-ok Lee, M.D., Seoul National University Bundang Hospital; Principal Investigator: Chul-won Jung, M.D., Seoul Medical Center; Principal Investigator: Sung-soo Yoon, M.D., Seoul National University Hospital; Principal Investigator: Kyung-ha Kim, M.D., Soonchunhyang University Hospital Seoul; Principal Investigator: Joon-sung Park, M.D., Ajou University School of Medicine; Principal Investigator: Duk-yeon Cho, M.D., Chungnam National University Hospital; Principal Investigator: Sung-nam Im, M.D., Inje University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2014
• Primary Completion (Actual): May 23, 2017
• Study Completion (Actual): January 9, 2018

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: IMA_CML_IV