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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Myeloid Leukemia
• Intervention / Treatment: Drug: Imatinib

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: imatinib，Capsule; 400mg imatinib qd	Drug: Imatinib; 400mg imatinib qd PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major molecular response	the rate of major molecular response in two years	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete cytogenetics response	the rate of complete cytogenetics response in one years	1 years
over survival	the rate of over survival in two years	2 years
progress free survival	the rate of progress free survival in two years	2 years

Collaborators and Investigators

• Sponsor: Cttq
• Collaborators: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 12, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Estimate): December 15, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: IMAGE-201