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

• Status: Terminated
• Trial end date: 2018-01-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Collaborator: SeoulCRO
• Treatments: Imatinib Mesylate

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