Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia

Phase 4

• Conditions: Chronic Myeloid Leukemia
• Interventions: Drug: Imatinib

• Registration Number: NCT02317159
• Lead Sponsor: Cttq

Brief Summary

This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in patients with chronic phase of Chronic Myeloid Leukemia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-12
• Last Update Submitted: 2014-12-12
• Study First Posted: 2014-12-15
• Last Update Posted: 2014-12-15
• Study Start: 2015-02
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age≥18；
• The new diagnosis of CML patients in six months；
• No proof of extra-medullary infiltration of leukemia；
• ECOG PS score：0-2；
• Hepatic and renal functions are normal，Serum bilirubin≤1.5*ULN, serum ALT and AST≤2.5*ULN, serum Cr≤1.5*ULN;
• Do not receive the treatment of anti-CML；
• Subjects signed informed consent form in line with GCP requirements。

Exclusion Criteria

• Pregnant or lactating women；
• Received TKIs any time before；
• Failure to control systemic infection or multiple organ failure；
• According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；
• Being diagnosed with other malignancies in the prior 12 months；
• Have a history of neurological or psychiatric disorders, including epilepsy or dementia；
• Known or suspected allergy to imatinib；
• BSA≤1.5m2；
• Using other experimental drugs or participating in other clinical trials in the prior one months。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
imatinib，Capsule	Imatinib	400mg imatinib qd

Primary Outcome Measures

Name	Time	Method
major molecular response	2 years	the rate of major molecular response in two years

Secondary Outcome Measures

Name	Time	Method
over survival	2 years	the rate of over survival in two years
complete cytogenetics response	1 years	the rate of complete cytogenetics response in one years
progress free survival	2 years	the rate of progress free survival in two years