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

NCT ID: NCT02317159

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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imatinib，Capsule

400mg imatinib qd

Group Type EXPERIMENTAL

Imatinib

Intervention Type DRUG

400mg imatinib qd PO

Interventions

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Imatinib

400mg imatinib qd PO

Intervention Type DRUG

Eligibility Criteria

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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。
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role collaborator

Cttq

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Zhixiang Shen, Master

Role: CONTACT

Phone: 13901651262

Other Identifiers

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IMAGE-201

Identifier Type: -

Identifier Source: org_study_id