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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02317159
Recruitment Status : Unknown
Verified December 2014 by Cttq.
Recruitment status was:  Not yet recruiting
First Posted : December 15, 2014
Last Update Posted : December 15, 2014
Sponsor:
Collaborator:
Ruijin Hospital
Information provided by (Responsible Party):
Cttq

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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: Imatinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia
Study Start Date : February 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: imatinib,Capsule
400mg imatinib qd
Drug: Imatinib
400mg imatinib qd PO




Primary Outcome Measures :
  1. major molecular response [ Time Frame: 2 years ]
    the rate of major molecular response in two years


Secondary Outcome Measures :
  1. complete cytogenetics response [ Time Frame: 1 years ]
    the rate of complete cytogenetics response in one years

  2. over survival [ Time Frame: 2 years ]
    the rate of over survival in two years

  3. progress free survival [ Time Frame: 2 years ]
    the rate of progress free survival in two years



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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。

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317159


Contacts
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Contact: Zhixiang Shen, Master 13901651262

Sponsors and Collaborators
Cttq
Ruijin Hospital

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Responsible Party: Cttq
ClinicalTrials.gov Identifier: NCT02317159     History of Changes
Other Study ID Numbers: IMAGE-201
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action