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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Dong-Wook Kim, MD, PhD; Seoul St. Mary's Hospital

More Information

• 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
• 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:

Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases