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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • Recruiting
    • Seoul st. mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Korean Adult CML or Ph positive ALL patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyzing the patterns and rate of BCR-ABL mutations in Asian CML and Ph positive ALL patients	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	9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the choice of second-line therapy	To describe about the choice of second-line therapy To describe outcome after emergence of resistance according to type of mutation	9 years

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ANTICIPATED): March 1, 2014
• Study Completion (ANTICIPATED): November 1, 2014

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (ESTIMATE): January 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 13, 2014
• Last Update Submitted That Met QC Criteria: January 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: mutation; imatinib resistance
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: KC10RSGI0437