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

CTTQ

Status and phase: Unknown; Phase 4

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Imatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02317159

IMAGE-201

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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。

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

imatinib，Capsule

Experimental group

Description:

400mg imatinib qd

Treatment:

Drug: Imatinib