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

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Cttq
• Collaborator: Ruijin Hospital
• Treatments: Imatinib Mesylate

Criteria

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。