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

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.

Conditions

• Chronic Myeloid Leukemia

Interventions

DRUG

600mg/day of Imatinib

DRUG

400mg/day of Imatinib

Sponsors & Collaborators

• SeoulCRO

  collaborator UNKNOWN

• Dong-A ST Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Kyu-Hyoung Lee, M.D. · Asan Medical Center

• Jin-hee Park, M.D. · Gachon University Gil Medical Center

• Chul-won Choi, M.D. · Korea University Guro Hospital

• Sae-ryun Lee, M.D. · Korea University Ansan Hospital

• Yong Park, M.D. · Korea University Anam Hospital

• Joo-sup Joeng, M.D. · Pusan National University Hospital

• Jung-ok Lee, M.D. · Seoul National University Bundang Hospital

• Chul-won Jung, M.D. · Seoul Medical Center

• Sung-soo Yoon, M.D. · Seoul National University Hospital

• Kyung-ha Kim, M.D. · Soonchunhyang University Hospital Seoul

• Joon-sung Park, M.D. · Ajou University School of Medicine

• Duk-yeon Cho, M.D. · Chungnam National University Hospital

• Sung-nam Im, M.D. · Inje University Haeundae Paik Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-13

Primary Completion

2017-05-23

Completion

2018-01-09

Countries

• South Korea

Study Locations