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

Chronic Myeloid Leukemia Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02204722
• Other study ID #: IMA_CML_IV
• Status: Terminated
• Phase: Phase 4
• Start date: October 13, 2014
• Est. completion date: January 9, 2018

Study information

• Verified date: June 2018
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: January 9, 2018
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• 600mg/day of Imatinib

• 400mg/day of Imatinib

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.	SeoulCRO

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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