Patterns of ABL Mutation in Asian With Imatinib Resistant Chronic Myeloid Leukemia and Ph Positive Acute Lymphocytc Leuekmia Patients (AMICA)
|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: 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
|Condition or disease|
|Chronic Myeloid Leukemia or Ph Positive ALL|
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.
|Study Type :||Observational|
|Estimated Enrollment :||125 participants|
|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|
All mutation data from CML and Ph positive ALL patients who developed imatinib resistance during the year 2001-2009
- 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
- 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
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
|Contact: Sahee Park, MSemail@example.com|
|Korea, Republic of|
|Seoul St. Mary's Hospital||Recruiting|
|Seoul, Korea, Republic of, 137-701|
|Contact: Sahee Park, MS +82-2-2258-7030 firstname.lastname@example.org|
|Principal Investigator:||Dong-Wook Kim, MD, PhD||Seoul St. Mary's Hospital|