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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02034656
Enrollment
125
Registered
2014-01-13
Start date
2010-07-31
Completion date
2014-11-30
Last updated
2014-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia or Ph Positive ALL

Keywords

imatinib resistance, mutation

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.

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.

Interventions

None listed

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Analyzing the patterns and rate of BCR-ABL mutations in Asian CML and Ph positive ALL patients9 yearsTo 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

MeasureTime frameDescription
Description of the choice of second-line therapy9 yearsTo describe about the choice of second-line therapy To describe outcome after emergence of resistance according to type of mutation

Countries

South Korea

Contacts

Primary ContactSahee Park, MS
saheepark@catholic.ac.kr+82-2-2258-7030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026