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Patterns of ABL Mutation in Asian With Imatinib Resistant Chronic Myeloid Leukemia and Ph Positive Acute Lymphocytc Leuekmia Patients (AMICA)

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ClinicalTrials.gov Identifier: NCT02034656
Recruitment Status : Unknown
Verified January 2014 by Dong-Wook Kim, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Dong-Wook Kim, Seoul St. Mary's Hospital

Brief Summary:
The purposes of this study are to investigate the patterns of BCR-ABL mutations in CML and Ph positive ALL patients with imatinib resistance during the year of 2001-2009 in Asian institutes.

Condition or disease
Chronic Myeloid Leukemia or Ph Positive ALL

Detailed Description:

Awareness of the significance of BCR-ABL mutations is generally low across Asia. This is partly due to historical limitations in capabilities for mutation testing. While numerous mutation studies have been done in non-Asian populations, there are very few published reports on mutations in Asians. CML management in Asia therefore continues to be largely intuitive.

Anecdotal reports, suggest that there may differences in the presence or absence of mutations at the time of initial diagnosis and their occurrence during imatinib treatment. At present, however, we have no comprehensive formal knowledge of the actual nature of mutations in Asians. There are moves towards the establishment of CML registries that will capture the pattern of mutations among Asian patients.

In recent years, several laboratories in the region have been performing mutation analysis. However, no systematic evaluation of or report on these data has been undertaken. This study therefore intends to collect documented mutation data in Asian CML and Ph positive ALL patients from identified Asian institutes. While this is a retrospective, cross-sectional analysis of mutation information, the study will provide the first comprehensive formal report on mutations in Asian CML and Ph positive ALL patients. The collecting information has the potential better to inform the clinical management of CML and Ph positive ALL in Asia according to the mutation result and possibly future research in these patients.

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Patterns of ABL Mutation in Asian With Imatinib Resistant Chronic Myeloid Leukemia and Ph Positive Acute Lymphocytc Leuekmia Patients (AMICA): A Retrospective Feasibility Study
Study Start Date : July 2010
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : November 2014


Group/Cohort
imatinib resistance
All mutation data from CML and Ph positive ALL patients who developed imatinib resistance during the year 2001-2009



Primary Outcome Measures :
  1. Analyzing the patterns and rate of BCR-ABL mutations in Asian CML and Ph positive ALL patients [ Time Frame: 9 years ]
    To describe the patterns and rate of BCR-ABL mutations in Asian CML and Ph positive ALL patients. To compare the patterns of BCR-ABL mutations to that of Non-Asian. To describe methods used in mutation analysis


Secondary Outcome Measures :
  1. Description of the choice of second-line therapy [ Time Frame: 9 years ]
    To describe about the choice of second-line therapy To describe outcome after emergence of resistance according to type of mutation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Korean Adult CML or Ph positive ALL patients
Criteria

Inclusion Criteria:

  • All mutation data from CML and Ph positive ALL patients who developed imatinib resistance during the year 2001-2009

Exclusion Criteria:

  • Mutation data from CML and Ph positive ALL patients who, in addition to imatinib, received other therapy. Follow up mutation report after second generation TKI therapy.

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): NCT02034656


Contacts
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Contact: Sahee Park, MS +82-2-2258-7030 saheepark@catholic.ac.kr

Locations
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Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Sahee Park, MS    +82-2-2258-7030    saheepark@catholic.ac.kr   
Sponsors and Collaborators
Seoul St. Mary's Hospital
Bristol-Myers Squibb
Investigators
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Principal Investigator: Dong-Wook Kim, MD, PhD Seoul St. Mary's Hospital
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Responsible Party: Dong-Wook Kim, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02034656    
Other Study ID Numbers: KC10RSGI0437
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014
Keywords provided by Dong-Wook Kim, Seoul St. Mary's Hospital:
imatinib resistance
mutation
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