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Korean Post-marketing Surveillance for Sprycel®

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: NCT01464047
Recruitment Status : Completed
First Posted : November 3, 2011
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.

Condition or disease
Leukemia, Myelomonocytic, Chronic Leukemia-Lymphoma

Study Type : Observational
Actual Enrollment : 670 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Post-marketing Surveillance for Sprycel®
Study Start Date : October 2011
Primary Completion Date : August 2015
Study Completion Date : August 2015


Group/Cohort
Patients with CML or Ph+ ALL



Primary Outcome Measures :
  1. Adverse events occurrence [ Time Frame: 30 days after last dose of study drug ]

Secondary Outcome Measures :
  1. Improvement in hematologic response [ Time Frame: 4 weeks after registration ]
    The number and percentage of subjects who satisfy each criterion of hematologic responses (Complete/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value

  2. Improvement in cytogenetic response [ Time Frame: 12 weeks after registration ]
    The number and percentage of subjects who satisfy each criterion of cytogenetic responses (Complete/Partial/Minor/Minimal/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value

  3. Overall efficacy assessment by investigator's discretion [ Time Frame: 4 weeks after registration ]
    Based on demographic factors, treatment factors like medical history and concomitant medication



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who were never treated with Sprycel®
Criteria

Inclusion Criteria:

  • Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
  • Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib
  • Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy

Exclusion Criteria:

  • According to Warning/Caution in local label

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): NCT01464047


Locations
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 110-756
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01464047     History of Changes
Other Study ID Numbers: CA180-370
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelomonocytic, Chronic
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action