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

NCT02317159 | Unknown Phase 4 DMC

• 1 other identifier: IMAGE-201
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• major molecular response

  the rate of major molecular response in two years

  2 years

Secondary Outcomes (3)

• complete cytogenetics response

  1 years

• over survival

  2 years

• progress free survival

  2 years

Study Arms (1)

imatinib，Capsule

EXPERIMENTAL

400mg imatinib qd

Drug: Imatinib

Interventions

Imatinib DRUG

400mg imatinib qd PO

imatinib，Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。

You may not qualify if:

• 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。

Sponsors & Collaborators

• Cttq: lead
• Ruijin Hospital: collaborator

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Zhixiang Shen, Master

CONTACT

13901651262

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 15, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 15, 2014

Record last verified: 2014-12