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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01564836 |
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Date of registration:
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26/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Discontinuation Study of Imatinib in Adult CP CML Patients Who Have a Complete Molecular Response to Imatinib
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Scientific title:
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A Multi-center Study of the Discontinuation of Imatinib in Adult Patients With Ph+ CML in CP Who Have a Complete Molecular Response to Imatinib |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01564836 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sahee Park, MS |
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Address:
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Telephone:
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+82-2-2258-7030 |
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Email:
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saheepark@catholic.ac.kr |
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Affiliation:
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Name:
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Sahee Park, MS |
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Address:
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Telephone:
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+82-2-2258-7030 |
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Email:
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saheepark@catholic.ac.kr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult (= 18 years-old) Ph+ CP CML patients who were treated with IM for more than 3
years in sustained MR4.5 or undetectable transcript for at least 2 years are
enrolled. MR4.5 or undetectable transcript must be sustained by 2 consecutive RQ-PCR
assay within 6 months
Exclusion Criteria:
- Patients were diagnosed with AP or BP CML
- Ph+ ALL
- Received cytotoxic chemotherapy or any other TKIs except imatinib
- Any evidence of on-going graft versus-host disease (GVHD)
- Relapsed patients after allogeneic stem cell transplantation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Complete Molecular Response
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Imatinib
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Chronic Myeloid Leukemia
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Intervention(s)
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Behavioral: Imatinib treatment discontinuing
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Primary Outcome(s)
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Probability of persistent undetectable molecular residual disease (UMRD) and MR4.5
[Time Frame: 12 months]
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Secondary ID(s)
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KC10ENME0465
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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