Back to results

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

Primary Purpose

Chronic Myeloid Leukemia

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Imatinib

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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。

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

imatinib，Capsule

Arm Description

400mg imatinib qd

Outcomes

Primary Outcome Measures

major molecular response

the rate of major molecular response in two years

Secondary Outcome Measures

complete cytogenetics response

the rate of complete cytogenetics response in one years

over survival

the rate of over survival in two years

progress free survival

the rate of progress free survival in two years

Full Information

NCT ID

NCT02317159

First Posted

December 11, 2014

Last Updated

December 12, 2014

Sponsor

Cttq

Collaborators

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02317159

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cttq

Collaborators

Ruijin Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Myeloid Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

imatinib，Capsule

Arm Type

Experimental

Arm Description

400mg imatinib qd

Intervention Type

Drug

Intervention Name(s)

Imatinib

Intervention Description

400mg imatinib qd PO

Primary Outcome Measure Information:

Title

major molecular response

Description

the rate of major molecular response in two years

Time Frame

2 years

Secondary Outcome Measure Information:

Title

complete cytogenetics response

Description

the rate of complete cytogenetics response in one years

Time Frame

1 years

Title

over survival

Description

the rate of over survival in two years

Time Frame

2 years

Title

progress free survival

Description

the rate of progress free survival in two years

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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。

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhixiang Shen, Master

Phone

13901651262

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs