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

Dong-A ST

Status and phase

Terminated

Phase 4

Conditions

Chronic Myeloid Leukemia

Treatments

Drug: 600mg/day of Imatinib

Drug: 400mg/day of Imatinib

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02204722

IMA_CML_IV

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No 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