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

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02317159
• Other study ID #: IMAGE-201
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 11, 2014
• Last updated: December 12, 2014
• Start date: February 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2014
• Source: Cttq
• Contact: Zhixiang Shen, Master
• Phone: 13901651262
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Imatinib
400mg imatinib qd PO

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cttq	Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major molecular response	the rate of major molecular response in two years	2 years	No
Secondary	complete cytogenetics response	the rate of complete cytogenetics response in one years	1 years	No
Secondary	over survival	the rate of over survival in two years	2 years	No
Secondary	progress free survival	the rate of progress free survival in two years	2 years	No