Clinical trial NCT02034656: Patterns of ABL Mutation in Asian With Imatinib Resistant Chronic Myeloid Leukemia and Ph Positive Acute Lymphocytc Leuekmia Patients (AMICA)
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Myeloid Leukemia or Ph Positive ALL
Keywords: imatinib resistance
mutation
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2014-01-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean Adult CML or Ph positive ALL patients

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.

Eligibility 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.

Primary outcomes:
measure: Analyzing the patterns and rate of BCR-ABL mutations in Asian CML and Ph positive ALL patients
timeFrame: 9 years
Secondary outcomes:
measure: Description of the choice of second-line therapy
timeFrame: 9 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Dong-Wook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: