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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02317159

Enrollment

Registered

2014-12-15

Start date

2015-02-28

Completion date

2017-07-31

Last updated

2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

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.

Interventions

DRUGImatinib

400mg imatinib qd PO

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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。

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactZhixiang Shen, Master

13901651262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026